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Ont Health Technol Assess Ser. 2009; 9(3): 1–203.
Published online Jul 1, 2009.
PMCID: PMC3377577
Management of Chronic Pressure Ulcers
An Evidence-Based Analysis
Health Quality Ontario
Presented to the Ontario Health Technology Advisory Committee in October 2008
In April 2008, the Medical Advisory Secretariat began an evidence-based review of the literature concerning pressure ulcers.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/tech/tech_mn.html to review these titles that are currently available within the Pressure Ulcers series.
  • Pressure ulcer prevention: an evidence based analysis
  • The cost-effectiveness of prevention strategies for pressure ulcers in long-term care homes in Ontario: projections of the Ontario Pressure Ulcer Model (field evaluation)
  • Management of chronic pressure ulcers: an evidence-based analysis
Objective
The Medical Advisory Secretariat (MAS) conducted a systematic review on interventions used to treat pressure ulcers in order to answer the following questions:
  • Do currently available interventions for the treatment of pressure ulcers increase the healing rate of pressure ulcers compared with standard care, a placebo, or other similar interventions?
  • Within each category of intervention, which one is most effective in promoting the healing of existing pressure ulcers?
Background
A pressure ulcer is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in conjunction with shear and/or friction. Many areas of the body, especially the sacrum and the heel, are prone to the development of pressure ulcers. People with impaired mobility (e.g., stroke or spinal cord injury patients) are most vulnerable to pressure ulcers. Other factors that predispose people to pressure ulcer formation are poor nutrition, poor sensation, urinary and fecal incontinence, and poor overall physical and mental health.
The prevalence of pressure ulcers in Ontario has been estimated to range from a median of 22.1% in community settings to a median of 29.9% in nonacute care facilities. Pressure ulcers have been shown to increase the risk of mortality among geriatric patients by as much as 400%, to increase the frequency and duration of hospitalization, and to decrease the quality of life of affected patients. The cost of treating pressure ulcers has been estimated at approximately $9,000 (Cdn) per patient per month in the community setting. Considering the high prevalence of pressure ulcers in the Ontario health care system, the total cost of treating pressure ulcers is substantial.
Technology
Wounds normally heal in 3 phases (inflammatory phase, a proliferative phase of new tissue and matrix formation, and a remodelling phase). However, pressure ulcers often fail to progress past the inflammatory stage. Current practice for treating pressure ulcers includes treating the underlying causes, debridement to remove necrotic tissues and contaminated tissues, dressings to provide a moist wound environment and to manage exudates, devices and frequent turning of patients to provide pressure relief, topical applications of biologic agents, and nutritional support to correct nutritional deficiencies. A variety of adjunctive physical therapies are also in use.
Method
Health technology assessment databases and medical databases were searched from 1996 (Medline), 1980 (EMBASE), and 1982 (CINAHL) systematically up to March 2008 to identify randomized controlled trials (RCTs) on the following treatments of pressure ulcers: cleansing, debridement, dressings, biological therapies, pressure-relieving devices, physical therapies, nutritional therapies, and multidisciplinary wound care teams. Full literature search strategies are reported in appendix 1. English-language studies in previous systematic reviews and studies published since the last systematic review were included if they had more than 10 subjects, were randomized, and provided objective outcome measures on the healing of pressure ulcers. In the absence of RCTs, studies of the highest level of evidence available were included. Studies on wounds other than pressure ulcers and on surgical treatment of pressure ulcers were excluded. A total of 18 systematic reviews, 104 RCTs, and 4 observational studies were included in this review.
Data were extracted from studies using standardized forms. The quality of individual studies was assessed based on adequacy of randomization, concealment of treatment allocation, comparability of groups, blinded assessment, and intention-to-treat analysis. Meta-analysis to estimate the relative risk (RR) or weighted mean difference (WMD) for measures of healing was performed when appropriate. A descriptive synthesis was provided where pooled analysis was not appropriate or not feasible. The quality of the overall evidence on each intervention was assessed using the grading of recommendations assessment, development, and evaluation (GRADE) criteria.
Findings
Findings from the analysis of the included studies are summarized below:
Cleansing
  • There is no good trial evidence to support the use of any particular wound cleansing solution or technique for pressure ulcers.
Debridement
  • There was no evidence that debridement using collagenase, dextranomer, cadexomer iodine, or maggots significantly improved complete healing compared with placebo.
  • There were no statistically significant differences between enzymatic or mechanical debridement agents with the following exceptions:
    • Papain urea resulted in better debridement than collagenase.
    • Calcium alginate resulted in a greater reduction in ulcer size compared to dextranomer.
    • Adding streptokinase/streptodornase to hydrogel resulted in faster debridement.
    • Maggot debridement resulted in more complete debridement than conventional treatment.
  • There is limited evidence on the healing effects of debridement devices.
Dressings
Hydrocolloid dressing was associated with almost three-times more complete healing compared with saline gauze.
  • There is evidence that hydrogel and hydropolymer may be associated with 50% to 70% more complete healing of pressure ulcers than hydrocolloid dressing.
  • No statistically significant differences in complete healing were detected among other modern dressings.
  • There is evidence that polyurethane foam dressings and hydrocellular dressings are more absorbent and easier to remove than hydrocolloid dressings in ulcers with moderate to high exudates.
  • In deeper ulcers (stage III and IV), the use of alginate with hydrocolloid resulted in significantly greater reduction in the size of the ulcers compared to hydrocolloid alone.
  • Studies on sustained silver-releasing dressing demonstrated a tendency for reducing the risk of infection and promoting faster healing, but the sample sizes were too small for statistical analysis or for drawing conclusions.
Biological Therapies
  • The efficacy of platelet-derived growth factors (PDGFs), fibroblast growth factor, and granulocyte-macrophage colony stimulating factor in improving complete healing of chronic pressure ulcers has not been established.
  • Presently only Regranex, a recombinant PDGF, has been approved by Health Canada and only for treatment of diabetic ulcers in the lower extremities.
  • A March 2008 US Food and Drug Administration (FDA) communication reported increased deaths from cancers in people given three or more prescriptions for Regranex.
  • Limited low-quality evidence on skin matrix and engineered skin equivalent suggests a potential role for these products in healing refractory advanced chronic pressure ulcers, but the evidence is insufficient to draw a conclusion.
Adjunctive Physical Therapy
  • There is evidence that electrical stimulation may result in a significantly greater reduction in the surface area and more complete healing of stage II to IV ulcers compared with sham therapy. No conclusion on the efficacy of electrotherapy can be drawn because of significant statistical heterogeneity, small sample sizes, and methodological flaws.
  • The efficacy of other adjunctive physical therapies [electromagnetic therapy, low-level laser (LLL) therapy, ultrasound therapy, ultraviolet light therapy, and negative pressure therapy] in improving complete closure of pressure ulcers has not been established.
Nutrition Therapy
  • Supplementation with 15 grams of hydrolyzed protein 3 times daily did not affect complete healing but resulted in a 2-fold improvement in Pressure Ulcer Scale for Healing (PUSH) score compared with placebo.
  • Supplementation with 200 mg of zinc three times per day did not have any significant impact on the healing of pressure ulcers compared with a placebo.
  • Supplementation of 500 mg ascorbic acid twice daily was associated with a significantly greater decrease in the size of the ulcer compared with a placebo but did not have any significant impact on healing when compared with supplementation of 10 mg ascorbic acid three times daily.
  • A very high protein tube feeding (25% of energy as protein) resulted in a greater reduction in ulcer area in institutionalized tube-fed patients compared with a high protein tube feeding (16% of energy as protein).
  • Multinutrient supplements that contain zinc, arginine, and vitamin C were associated with a greater reduction in the area of the ulcers compared with standard hospital diet or to a standard supplement without zinc, arginine, or vitamin C.
  • Firm conclusions cannot be drawn because of methodological flaws and small sample sizes.
Multidisciplinary Wound Care Teams
  • The only RCT suggests that multidisciplinary wound care teams may significantly improve healing in the acute care setting in 8 weeks and may significantly shorten the length of hospitalization. However, since only an abstract is available, study biases cannot be assessed and no conclusions can be drawn on the quality of this evidence.
In April 2008, the Medical Advisory Secretariat began an evidence-based review of the literature concerning pressure ulcers.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/tech/tech_mn.html to review these titles that are currently available within the Pressure Ulcers series.
  • Pressure ulcer prevention: an evidence based analysis
  • The cost-effectiveness of prevention strategies for pressure ulcers in long-term care homes in Ontario: projections of the Ontario Pressure Ulcer Model (field evaluation)
  • Management of chronic pressure ulcers: an evidence-based analysis
Objective
The objective of this analysis is to review a spectrum of pressure ulcer treatments to identify whether there are any treatment modalities that are more effective than others in promoting complete closure of pressure ulcers in the various health care settings. This evidence-based analysis reviews local wound care (cleansing, debridement, topical agents, dressings, and biological therapies), pressure relieving supportive surfaces, adjunctive physical therapies, nutrition therapy, and multidisciplinary wound care teams.
Pressure Ulcers
Definition and Location
According to the National Pressure Ulcer Advisory Panel (NPUAP), (1) a pressure ulcer is defined as a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction. The sacrum and heel are the most common location of pressure ulcers. Other areas that are prone to the development of pressure ulcers are shown in Figure 1.
Figure 1:
Figure 1:
Common Locations of Pressure Ulcers
Copyright © 2006 American Medical Association. All rights reserved.
Reproduced with permission from: Zeller JL, Lynm C, Glass RM. JAMA patient page. Pressure ulcers. JAMA 2006; 296 (8): 1020.
Risk Factors for Developing Pressure Ulcers
Prolonged, uninterrupted pressure is the main cause of pressure ulcers and impaired mobility is the most common reason that people are exposed to unrelieved pressure. People with impaired mobility such as stroke patients, patients with spinal cord injury, or unconscious patients, are at risk of developing pressure ulcers as they are not able to shift their position to relieve pressure. Many of these patients also have other conditions that contribute to poor tissue viability including loss of loss of muscle and adipose due to immobility and poor nutrition, poor sensation, urinary and fecal incontinence, and poor overall physical and mental health.
Many tools have been developed to assess individuals’ risks of developing a pressure ulcer. These tools are generally based on an assessment of the above-mentioned risk factors. The most often used tool is the Braden scale.
Classification of Pressure Ulcers
There are different systems for classifying a pressure ulcer based on their severity, taking into consideration the surface area and depth of the ulcer, the tissues affected, and presence or absence of necrosis, exudate, and slough. The most commonly used system is the North American National Pressure Ulcer Advisory Panel (NPUAP) system and the European Pressure Ulcer Advisory Panel System (Appendix 1). Characteristics of the stages are summarized in Table 1. Stage I usually refers to a change in the skin without breakage. Stage II refers to a shallow ulcer with partial thickness skin loss. Stages III and IV are considered advanced ulcers with full thickness skin loss affecting tissues beneath the dermis. A new category was recently added to represent damage of underlying soft tissues while the skin remained intact.
Table 1:
Table 1:
Characteristics of Stages of Pressure Ulcers
Since pressure ulcers do not heal by regeneration and various strata (e.g., muscle, fascia, subcutaneous) are not replaced, pressure ulcers should not be reverse staged (e.g., from stage IV to stage III) as they heal.
Two other tools are often used to assess the status of a pressure ulcer. The Pressure Sore Status Tool (PSST) assesses a pressure ulcer condition based on 13 parameters each measured on a Likert scale of 1 to 5. The total score ranges from 13 to 65 with the score of 13 indicating a healed ulcer. The 13 parameters are as follows:
  • Size (length times width)
  • Depth
  • Edges
  • Undermining
  • Necrotic tissue type
  • Necrotic tissue amount
  • Exudate type
  • Exudate amount
  • Skin color surrounding wound
  • Peripheral tissue edema
  • Peripheral tissue induration
  • Granulation tissue
  • Epithelialization
The PUSH scores a pressure ulcer based on its surface area, amount of exudates, and the type of tissue present (e.g., granulation). The total score ranges from 0 (healed ulcer) to 17 (> 24cm2 with heavy exudates and necrosis).
Prevalence of Pressure Ulcers
Woodbury et al. (2) conducted a systematic review to determine the prevalence of pressure ulcers in health care settings across Canada. The review combined data that surveyed more than 14,000 patients from 45 health care institutions across Canada. The results of the review are summarized in Table 2. On the average, 1-in-4 patients across Canadian health care settings suffered from a pressure ulcer (median prevalence regardless of health care setting = 26%).
Table 2:
Table 2:
Prevalence of Pressure Ulcers in Canada and Ontario by Health Care Setting
Burden of Illness
The impact of pressure ulcers can be seen in human and economic terms. In human terms, the geriatric patient who develops a pressure ulcer has a four-fold increased risk of death. (3) Pressure ulcers also affect quality of life and lead to more frequent hospitalization. In economic terms, the cost of healing a pressure ulcer is likely high because it often involves a multitude of prolonged complex treatments and hospitalization. Once a pressure ulcer reaches stage III or IV, it may take as long as 6 months to heal. Experts advise that some ulcers may not be healable because of existing comorbidities and may require ongoing treatment and care. (Campbell) In a 2004 case study, Allen and Houghton (4) estimated that the total cost for 3 months of care of a person with a stage III pressure ulcer in the community was $27,500 per patient. This amount included reimbursement for professional and support staff, wound care supplies, electrical stimulation, rental of equipment, and loss of potential income.
In Ontario, the Ministry of Health and Long-Term Care provides a claims-based supplementary High Intensity Fund (HINF) to long-term care facilities to help finance care for medically complex residents. Of the $31.9 million HINF provided to long-term care facilities in 2006, 65% were claimed for wound care. (E-mail communication, 2007)
In the United States, the national expenditure for costs related to the care of patients with pressure ulcers in 1998 were estimated to be more than $1.3 billion per year. (5) This number is expected to increase at a high rate as the population over age 85 will increase from 4 million to 17 million over the 15 years since this cost study. (6)
Process of Wound Healing
There are three phases in wound healing:
  • Inflammatory Phase – This phase begins the moment the tissue is injured as blood components spill into the site of injury, triggering platelets to release clotting factors, essential growth factors, and
  • Proliferative Phase – This phase begins once the wound site is cleaned out and is marked by migration of fibroblasts, proliferation of new tissues, and deposition of extracellular matrix.
  • Remodelling Phase – In this final phase, the new collagen matrix becomes cross-linked and organized through numerous cell-signalling events. (6)
In nonhealing pressure ulcers, the above process is lost and the ulcers are locked into a state of chronic inflammation that prevent them from healing. (6)
Pressure Ulcer Prevention
Pressure ulcer prevention aims to eliminate or reduce factors that predispose a person to pressure ulcer development. The prevention strategies commonly used include regular risk assessment, use of special pressure relieving support surfaces, regular repositioning and turning, local skin care, and nutrition support. Pressure ulcer prevention is addressed in a separate MAS systematic review.
Factors Influencing Healing
Many variables that can affect ulcer healing, including patient demographics, pressure ulcer size and severity, and pressure ulcer management practices. Retrospective multivariate regression analysis of databases had been performed to identify factors that influence healing of pressure ulcers (Appendix 2).
Based on these studies, patient-related variables that were significantly associated with improved healing included higher body weight and lower body temperature, (7) whereas comorbid cardiovascular disease, incontinence, and immobility were associated with decreased odds of pressure ulcer healing. (8;9)
The size of the ulcer also has an impact on likelihood of healing. Vu et al. (10) found that for every 1 mm increase in the width of the wound at enrolment, the chance of healing decreased by 4.0% [RR 0.96 (95% confidence interval (CI) 0.95–0.98), P = .000]. Deep wounds had a 60% reduced chance of healing compared with superficial wounds [RR 0.40 (95% CI, 0.25–0.62), P = .000]. (10) Graumlich et al. (11) also reported that deep ulcers at randomization decrease the chance of healing compared with superficial ulcers [odds ratio (OR) = 0.56 (95% CI, 0.38–0.81), P = .002].
Several treatment variables were identified to be significantly associated with improved healing of pressure ulcers:
  • Moist dressing (in stage II and stage III/IV ulcers) (12)
  • Receiving sufficient enteral feeding (> 30 kcal/kg) (12)
  • Use of exudate management dressing (8)
  • Rehabilitation services (9)
Treatment variables associated with decreased odds of pressure ulcer healing were:
  • Frequent changes in dressing types with indications of inappropriate changes (8)
  • Failure to use exudate management dressing in ulcers with large to moderate amount of exudate (8)
  • Lack of debridement in pressure ulcers with yellow slough (8)
Technology
Pressure ulcers are marked by excessive infiltration of neutrophils, which are believed to be responsible for the chronic inflammation characteristics of nonhealing pressure ulcers. (6) The neutrophils release significant amounts of enzymes that destroy the connective tissue matrix and an elastase that is capable of destroying important healing factors. Chronic pressure ulcers will not respond to treatment until the wound bed is properly prepared. (6) Experts suggest that adequate wound bed preparation consists of four main components represented by the acronym DIME: debridement of necrotic tissues, control of infection, providing a moist wound environment, and dealing with the edge effect (when the edge fails to close). Hence local wound care is the cornerstone for the treatment of pressure ulcers. (13)
Present treatment of pressure ulcers focuses on:
  • Treating the underlying disease and addressing patient-centred concerns
  • Local wound care (DIME) including cleansing, debridement of necrotic tissues, appropriate dressing to provide a moist environment for healing, and topical biological therapies (e.g. topical growth factors) to facilitate healing
  • Adjunctive physical therapies such as electrical stimulation, electromagnetic stimulation, LLL therapy, ultrasound therapy, ultraviolet radiation, and negative pressure therapy
  • Providing nutrition support to correct nutritional deficiencies
  • Providing pressure relief using special support beds, mattresses, overlays, cushions, and regular turning schedules
  • Integration of wound care through multidisciplinary wound care teams
  • Surgical repair
This MAS systematic review includes all of the above with the exception of treatment for underlying diseases, turning, and surgical repair. Drug treatment for infection control is also outside the scope of this review.
Objectives
To systematically assess the evidence for the effectiveness of interventions used in the treatment of pressure ulcers.
Questions
  • Do currently available interventions for the treatment of pressure ulcers increase the healing rate of pressure ulcers compared with standard care, placebo, or another similar intervention?
  • Within each category of interventions, which one is most effective in promoting healing of existing pressure ulcers?
Method
Search Strategy
Initially, 1 search was run on August 6, 2007, to capture all treatment modalities. This search covered the literature published between January 1996 and August 2007. Separate search strategies were then developed to address each category of intervention included in the systematic review (see inclusion criteria) for the period of January 2003 to March 2008. The detailed search strategies are shown in Appendix 3. All final searches were run between March 10 and March 30, 2008 in the following databases: OVID MEDLINE, OVID MEDLINE In-Process and Other Nonindexed Citations, OVID EMBASE, OVID CINAHL, Cochrane Library, and the INAHTA/CRD database. All searches were limited to human subjects and English-language articles. Additional searches of websites and references of publications were also performed to ensure comprehensiveness.
Selection of Articles
One researcher screened the citations and abstracts from the literature search and selected articles according to the following inclusion and exclusion criteria. Full text reports were obtained if there were no abstracts or when the abstract was unclear.
Inclusion Criteria
  • English language systematic reviews and RCTs that meet the following description:
    • Patients: in any setting, with one or more pressure ulcers
    • Interventions: nondrug and nonsurgical treatments for pressure ulcers including:
      • Local wound therapy – cleansing agents, topical treatments, debridement agents and devices, dressings, and biological therapy
      • Adjunctive physical therapies – hydrotherapy, electrical stimulation, electromagnetic therapy, ultrasound therapy, LLL therapy, and negative pressure therapy
      • Pressure relieving support surfaces – beds, mattresses, overlays, and cushions
      • Nutrition therapy – supplementation of macro or micronutrients alone or in combination
      • Multidisciplinary wound care teams
    • Comparison: an intervention versus a placebo, a sham treatment, or another intervention
    • Outcome of interest: proportion of ulcers that healed completely (closed), percent change in surface area/volume, rate of change in surface area (cm2/day or week), mean time to achieve complete healing, change in the amount of exudate, granulation, PSST score, PUSH score, treatment-related adverse events, and absorbency and ease of removal (for dressings)
  • Clinical controlled trials or other observational studies only if RCTs are not available
  • Sample ≥ 10 ulcers
Exclusion Criteria
  • Studies on acute wounds or chronic wounds other than pressure ulcers
  • Studies with only subjective outcomes
  • Nonsystematic reviews or case reports (except where indicated)
  • Opinion articles or letters to the editor that provided no primary data
  • Studies for which results have already been reported or for which a more current update is available
  • Full text articles in a language other than English
  • Studies on surgical reconstruction of pressure ulcers
Results
The results of the literature searches are summarized in summarized in Table 3.
Table 3:
Table 3:
Results of Literature Searches
The number of studies from previous systematic reviews and studies identified from this literature search are summarized in Table 4.
Table 4:
Table 4:
Level of Evidence of Included Studies*
Quality Assessment and Data Abstraction
One researcher reviewed the full-text reports and extracted data using data extraction tables. For RCTs, the quality of studies was assessed using the following criteria:
  • Method of randomization described and adequate
  • Concealment of allocation described and adequate
  • Inclusion and exclusion criteria described
  • A priori sample size calculation described
  • Blinded assessment of outcomes employed
  • Attrition reported and explained
  • Intention-to-treat analysis conducted
The quality of observational studies was evaluated based on method of patient selection, sample size, statistical analysis, and completeness of follow-up. The quality assessment of the included studies is summarized in Appendix 4.
Analysis and Synthesis of Evidence
When appropriate, Revman 4.2 (the Cochrane meta-analysis software) was used to test for heterogeneity and to estimate the RRs for complete healing of pressure ulcers. Weighted mean differences were estimated for mean reduction in ulcer size and mean time to achieve complete healing. A point estimate with the 95% CI was generated when appropriate. A descriptive synthesis was provided when statistical analysis was not feasible.
Grading Quality of Evidence
The overall quality of evidence was examined according to the GRADE Working Group criteria (15;16). This system rates the overall quality of evidence based on the assessment of 4 key elements:
  • Study design – broadly categorized as randomized trials and observational studies.
  • Quality of included studies – refers to whether there were limitations relating to the methods and exaction that may result in biases. The assessment is based on appropriate criteria such as adequacy of allocation concealment, blinding, and follow-up.
  • Consistency of outcomes – refers to similarity of estimates of effect across studies. If there is important unexplained inconsistency in the result, confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of differences in effect, and the significance of the differences guide the decision about whether important inconsistency exists.
  • Directness – refers to the extent to which the subjects, interventions, and outcome measure are similar to those of interest.
As stated by the GRADE Working Group, the following definitions were used in grading the quality of evidence:
  • High: further research is very unlikely to change our confidence in the estimate of effect,
  • Moderate: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate,
  • Low: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate, and
  • Very low: any estimate of effect is very uncertain.
The GRADE quality of evidence is summarized in Appendix 5.
The studies are summarized in detail in Appendix 6.
Analyses of findings are reported in the following order:
Local pressure ulcer treatment:
  • Wound cleansing
  • Debridement
    • Chemical (enzymatic) debridement
    • Mechanical debridement
    • Autolytic debridement (compared with the above)
    • Biological debridement – maggot debridement
    • Devices for debridement
  • Topical treatment
  • Dressing
    • Modern dressings versus traditional dressings
    • Modern dressings versus modern dressings
Biological therapies
  • Growth factors
  • Engineered skin equivalents and skin matrix
Pressure-relieving support services
Adjunctive physical therapies
  • Hydrotherapy
  • Electrotherapy
  • Electromagnetic therapy
  • LLL therapy
  • Ultrasound therapy
  • Negative pressure therapy
Nutrition therapy
  • Protein supplement
  • Zinc supplement
  • Ascorbic acid supplement
  • Multi-nutrient supplements
Multidisciplinary wound care teams
Local Wound Care
Cleansing of Pressure Ulcers
Cleansing of the pressure ulcer is assumed to be an important component of pressure ulcer care. In a 2005 systematic review, Moore and Cowman (17) assessed the effects of wound cleansing solutions and wound cleansing techniques on the healing rates of pressure ulcers. The review included RCTs and controlled clinical trials in the absence of RCTs. No studies comparing cleansing with no cleansing were found. Three studies that addressed cleansing of pressure ulcers were found and these are summarized in Table 5. The MAS literature search did not find any other studies on this subject.
Table 5:
Table 5:
Randomized Controlled Trials on Cleansing of Pressure Ulcers*
Two of the 3 RCTs compared different cleansing solutions. Griffiths et al. (18) compared 20 patients whose wounds were cleansed with tap water to 23 patients whose wounds were cleansed with normal saline solution for a period of 6 weeks. Only 6 of the wounds in the tap water group and 2 of the wounds in the saline group were pressure ulcers. The wounds were grade 2 (partial thickness skin loss) and grade 3 (full thickness skin loss down to the fascia) according to Carville’s definition. Wound cleansing in both groups were achieved using a 30 mL syringe and a 20 g canola. Hydrocolloid and or gel and a clean dressing were applied after the wound was patted dry. After 6 weeks, 3 of the 6 pressure ulcers cleansed with tap water had healed but neither of the pressure ulcers cleansed with saline had healed. The difference in complete healing between the two groups was not statistically significant (Figure 2). Moore and Cowman (17) stated that the sample size was too small to draw any conclusion.
Figure 2:
Figure 2:
Forest Plot of Ulcers Healed – Tap Water Versus Normal Saline Cleansing*
* CI indicates confidence interval; RR, relative risk.
In another RCT, Bellingeri compared cleansing with Volnopur® (contains saline, aloe vera, silver chloride, and decyl glucoside) to cleansing with isotonic saline spray in patients with pressure ulcers greater than grade 1 in the NPUAP scale. The Volnopur group consisted of 39 subjects with a mean PSST score of 34 (standard deviation [SD] 11.5) and the 74-subject saline group had a mean baseline PSST score of 33 (SD 10.3). After 2 weeks and withdrawal of 7 patients, the mean percentage change from baseline in PSST score was –27.8% (SD 31.3%) in the Volnopur group compared with –20.5% (SD 24.1%) in the isotonic saline group. Bellingeri et al. reported that the difference in change of PSST scores between the groups was statistically significant in favour of Volnopur (P = .025). Moore and Cowman stated that since the data from this study were skewed, the nonparametric tests used in the study could not be reproduced without the raw data. It is not appropriate to compare the groups using RevMan since this software assumes a normal distribution.
In the third RCT, 24 grade 3 or 4 pressure ulcers treated with 20 minutes per day of whirlpool were compared with 18 pressure ulcers that did not receive whirlpool treatment. At the end of 2 weeks, 14 of the whirlpool group versus 5 of the control group showed improvement. The author reported a statistically significant difference (P = .0435). However, as reported by Moore and Cowman, RevMan analysis showed that the difference between the 2 groups was not statistically significant [RR 2.10 (95% CI, 0.93– 4.76), P = .08]. This study will be discussed in greater detail in the hydrotherapy section.
Based on the above studies, Moore and Cowman concluded that overall, there is no good trial evidence to support the use of any particular wound cleansing solution or technique for pressure ulcers.
Debridement
Debridement refers to the removal of necrotic or infected tissues and excess moisture from a wound that may impair proper wound healing. Necrotic tissues must be removed in order for granulation and re-epithelialization to occur. (21) Debridement may also control infection and stimulate a nonadvancing wound edge. Debridement may be selective, removing only necrotic tissues, or nonselective, removing or damaging healthy tissues as well as necrotic tissues. Traditionally, debridement was achieved by applying a mesh gauze dressing to the ulcer, moistened with saline, povidone-iodine, or Dakin’s solution, and then removing the dressing after drying. This nonselective method of debridement can damage granulation tissue and new epithelium in the wound and the process can be painful. Presently, there are a variety of approaches to debridement, summarized in Table 6.
Table 6:
Table 6:
Comparison of Debridement Methods
MAS Review of Debridement
This review focused on nonsurgical debridement techniques. No new studies on nonsurgical debridement were found in the MAS literature search. Studies from previous systematic reviews are discussed. These are shown in Table 7 and reviewed in the following sections.
Table 7:
Table 7:
Studies Comparing Debriding Agents*
Chemical (Enzymatic) Debridement: Collagenase Versus Placebo
Two studies compared collagenase debridement to a placebo treatment. Lee and Ambrus (24) compared the treatment of 17 advanced pressure sores using a topical collagenase preparation (250 units per gram of white petroleum) to 11 pressure sores treated with a placebo (deactivated collagenase in the same concentration) for 4 weeks. Both arms showed an increase in the mean volume of the pressure ulcer but the increase was significantly smaller in the collagenase arm than in the placebo arm (Figure 3).
Figure 3:
Figure 3:
Forest Plot of Mean Percentage Change in Volume of Ulcers – Collagenase Versus Placebo*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
In a 3-arm study, Parish and Collins (25) included a comparison of collagenase debridement of 11 pressure ulcers for 4 weeks to treatment of 9 pressure ulcers with a placebo (sugar and egg white). At follow-up, no significant difference was detected in the proportion of ulcers healed between the collagenase group and the placebo group (Figure 4).
Figure 4:
Figure 4:
Forest Plot of Ulcers Healed – Collagenase Versus Placebo*
*CI indicates confidence interval; RR, relative risk.
Chemical (Enzymatic) Debridement: Collagenase Versus Hydrocolloid Dressing (Autolytic Debridement)
Two small RCTs (26;27) were found. Both studies compared debridement of advanced pressure ulcers (stage III in one study and stage IV in the second study) using topical collagenase to autolytic debridement using an occlusive hydrocolloid dressing in elderly hospitalized patients. These studies are summarized in Table 8.
Table 8:
Table 8:
Randomized Studies Comparing Collagenase With Hydrocolloid Dressing for the Debridement of Pressure Ulcers*
Neither of the studies reported a significant difference in the proportion of ulcers with complete healing, and Burgos et al. (26) also reported no significant difference in the reduction of the size of stage III ulcers between the two arms (44.2% for collagenase vs. 27.9% for hydrocolloid dressing, P = .369). Muller et al., (27) who studied patients with stage IV ulcers, reported that even though there was no statistically significant difference in complete healing between the collagenase arm and the hydrocolloid arm, ulcers debrided with collagenase healed faster compared with patients treated with hydrocolloid dressing (mean time to achieve complete healing: 10 weeks vs. 14 weeks, P < .05). Burgos et al. (26) reported that collagenase debridement resulted in lower mean global cost for each centimetre reduction in ulcer area, and Muller reported that collagenase debridement resulted in a lower average cost for each successfully treated patient.
A pooled analysis of the proportion of ulcers with complete closure was conducted for the two studies. The test for heterogeneity is insignificant (I2 = 0%). The pooled estimate for RR showed no evidence of a significant difference between the 2 debridement methods (RR 1.33 in favour of hydrocolloid; 95% CI, 0.80–2.23) (Figure 5).
Figure 5:
Figure 5:
Forest Plot of Ulcers Healed – Collagenase Versus Hydrocolloid*
*CI indicates confidence interval; RR, relative risk.
Enzymatic Debridement: Collagenase Debridement Versus Other Topical Debriding Agents
Three studies (22;28) compared topical collagenase treatment to 3 other topical debriding agents. (Table 9).
Table 9:
Table 9:
Randomized Controlled Trials Comparing Collagenase Debridement to Other Debriding Agents*
In an RCT, Pullen et al. (28) compared 66 patients with stage II to III pressure ulcers treated with collagenase ointment twice daily to 69 similar patients treated with fibrinolysin/deoxyribonuclease ointment twice daily. After 4 weeks of treatment, Pullen et al. (28) found no significant difference in the reduction in necrotic wound area either by intention-to-treat analysis or by protocol analysis (Figure 6).
Figure 6:
Figure 6:
Forest Plot of Mean Change in Necrotic Area – Collagenase Versus Fibronolysin/DNAase*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
In another RCT, Alvarez et al. (22) compared 14 patients treated with papain-urea ointment for 4 weeks to 12 patients treated with topical collagenase for the same period of time. The primary endpoint was reduction of area covered by nonviable tissue as a percentage of the area at baseline. After 4 weeks of treatment, Alvarez et al. (22) reported that compared with treatment with collagenase, treatment with papain-urea resulted in significantly greater reduction in area covered with nonviable tissues (99% vs. 25%, P = .0053), a higher degree of granulation (75%–100% vs. < 25%, P < .0167), and a greater increase in the amount of epithelial tissue; however, there was no significant difference in the area of the wound and in the overall wound condition between the two arms.
In a placebo-controlled study, Parish and Collins (25) compared debridement using collagenase to debridement using dextranomer and treatment with a placebo (sugar and egg white). The study included 17 residents of a nursing home with a total of 34 pressure ulcers among them. After wound cleansing with saline, 11 of the pressure ulcers were treated a daily application of a collagenase enzyme (Santyle®) and covered with a dry dressing while 14 of the ulcers were treated with dextranomer polysaccharide beads applied 1 to 3 times and covered with a dry dressing. Nine other ulcers were treated with the mixture of sugar and egg whites After 4 weeks, none of the wounds treated with the placebo had healed. The ulcers treated with dextranomer showed better healing than those treated with collagenase, but the difference was not statistically significant (Figure 7).
Figure 7:
Figure 7:
Forest Plot of Ulcers Healed – Dextranomer Versus Collagenase*
*CI indicates confidence interval; RR, relative risk.
Table 10:
Table 10:
Summary of Results on Debridement Using Collagenase
Enzymatic Debridement: Streptokinase/Streptodornase
Streptokinase/streptodornase (Varidase®) consists of two enzymes believed to have two separate modes of action. Streptokinase acts directly upon a substrate of fibrin or fibrinogen by activating a fibrinolytic enzyme in human serum. Streptodornase liquefies the vicious nucleoprotein of dead cells or pus.
Agren and Stromberg (29) randomized 28 elderly patients with one or more necrotic pressure sores to either streptokinase/streptodornase enzymatic debridement (Varidase Topical) or zinc oxide applied to a sterile gauze compress dressing (Table 11). No surgical debridement was performed but loose necrotic material was removed prior to initiation of treatment. Wound area was assessed through tracing and photograph and evaluated by a surgeon blinded to treatment allocation. At the end of the treatment period, ulcers treated with streptokinase/streptodornase had a median increase of 18.7% in surface area whereas ulcers treated with zinc oxide had a median decrease of 2.4% in surface area. Three patients withdrew from the enzymatic debridement group because of skin reaction or increase in necrotic area.
Table 11:
Table 11:
Streptokinase/Streptodornase Versus Traditional Dressing
Enzymatic Debridement: Streptokinase/Streptodornase Debridement in Hydrogel Versus Hydrogel Alone
One small double-blind RCT by Martin et al. (21) compared debridement using enzymes streptokinase and streptodornase mixed with hydrogel to debridement using hydrogel alone. The study consisted of 17 patients (mean age 81 years) with 21 stage IV necrotic pressure sores. Martin et al. (21) reported that there were no statistically significant differences in the mean time to eschar removal between the two groups (11.8 [SD 2.9] days for the enzyme plus hydrogel group vs. 8.1 [SD 1.8] days for hydrogel alone). The author concluded that if the results were confirmed, using hydrogel alone would be equally effective as using streptokinase/streptodornase in combination with hydrogel, and the cost of debriding agents would be £2.40 instead of £85.80. (21)
Mechanical Debridement
Mechanical Debridement: Dextranomer Versus Collagenase or Advanced Dressings
Dextranomer paste contains polysaccharide beads that are highly hydrophilic, drawing moisture away from the wound surface by capillary action and is capable of drawing nonviable debris from the wound bed. (32) Six RCTs on the use of debridement were found. One study compared dextranomer paste with another debriding enzyme (collagenase), 2 with a traditional dressing, and 3 with autolytic debridement using advanced moisture retentive dressings (Table 12).
Table 12:
Table 12:
Randomized Controlled Trials Comparing Dextranomer Paste With Other Treatments for Pressure Ulcers*
Parish and Collins (25) compared dextranomer debridement with another debriding enzyme collagenase and with a placebo. This study reported that dextranomer debridement resulted in a higher proportion of completely healed ulcers compared with debridement with collagenase (43% vs. 9%) or with placebo (43% vs. 0%). The study, however, consisted of only 17 patients and 37 ulcers.
Nasar and Morley (30) compared dextranomer debridement in 9 patients with deep pressure ulcers to Eusol and paraffin dressing in 9 controls. Eusol is a disinfectant solution containing chlorinated lime and boric acid. Hardened slough present in the pressure ulcer was cut off before initiation of the treatment. The only other concurrent treatment was ultraviolet light. After a maximum treatment period of 94 days, there was no significant difference in the percent of ulcers that reached the endpoint (a clean and granulating wound less than 25% of the original size). The mean time to reach endpoint was shorter for dextranomer compared with Eusol (39.3 days vs. 62 days). Three ulcers in the Eusol group were switched to dextranomer. It should be noted that Eusol may cause irritation to skin surrounding the ulcer and thus protection of the periwound area with soft paraffin or vaseline has been recommended.
Ljungberg et al. (31) compared dextranomer paste with saline dressing (no debridement) in stage II to IV ulcers. There was a significant improvement in drainage and decrease in necrosis in the dextranomer group without any significant difference in granulation or epithelialization of the wounds.
Two studies compared dextranomer debridement with autolytic debridement using topical amorphous hydrogel. In the first study, Collins et al. (1996) compared dextranomer paste with an amorphous hydrogel in the debridement of 64 sloughy grade 2 to grade 4 pressure ulcers. After 3 weeks, both treatments were found to be equally efficacious in reducing the area of nonviable tissues (74% for amorphous hydrogel vs. 62% for dextranomer, P = .20). The proportion of ulcers with complete debridement was similar (14/68 in dextranomer vs. 13/67 in hydrogel). However, amorphous hydrogel was found to have a greater impact in reducing the wound area compared with dextranomer paste (35% vs. 7%, P = .03). The second study (33) compared 20 pressure ulcers debrided using dextranomer to 19 ulcers debrided using an amorphous hydrogel. The proportion of ulcers with complete debridement was also not significantly different between the 2 groups (5/20 vs. 8/20). A pooled analysis of the two studies showed that both hydrogel and dextranomer paste were equally effective in achieving complete debridement (Figure 8) but more patients reported leakage through the dressing in the group treated with hydrogel. Cost analysis showed that cost of using hydrogel was substantially less than that of dextranomer paste. (33)
Figure 8:
Figure 8:
Forest Plot of Complete Debridement – Dextranomer Paste Versus Topical Hydrogel*
*CI indicates confidence interval; RR, relative risk.
In a prospective randomized study involving 92 patients and 92 stage III to IV established pressure ulcers in a high-risk population (with immobilization, poor metal status, poor health status, and a high proportion of urinary and fecal incontinence), Sayag et al. (34) compared 47 ulcers treated with calcium alginate dressing with 45 ulcers treated with dextranomer paste. The authors reported that after 8 weeks of treatment, calcium alginate dressing performed significantly better than dextranomer paste in achieving a minimum of 40% reduction (relative to baseline) in the wound area (74% vs. 42%, P = .002) and in the rate of wound healing (3.55 cm2/week vs. 2.15 cm2/week, P = .024) (Figure 9). Adverse events associated with dextranomer paste debridement included pain upon application, local infection, slight bleeding on removal, and hypergranulation. These events generally did not require termination of treatment. (34)
Figure 9:
Figure 9:
Forest Plot of Ulcer Area Reduction – Calcium Alginate Versus Dextranomer*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
The limited evidence available suggests that the use of dextranomer paste is likely better than the use of traditional dressing alone. There is no significant difference between dextranomer paste and collagenase in terms of ulcers healed. Autolytic debridement of stage II to IV pressure ulcers using amorphous hydrogel or calcium alginate was shown to be as effective as debridement using dextranomer paste and resulted in significantly greater and faster reduction in the wound area compared with dextranomer paste. Calcium alginate was also shown to be effective in debriding even sloughy pressure ulcers.
Antimicrobial Mechanical Debridement: Cadexomer Iodine Versus Standard Treatment
Cadexomer iodine consists of spherical microbeads with a three-dimensional network of modified starch. The microbeads contain iodine within its matrix. When applied to the wound, the highly hydrophilic microbeads absorb exudate from the wound surface, swelling to form a gel, and progressively release iodine at the wound surface. One gram of powder can absorb as much as 7 mL of fluid. Cadexomer iodine promotes an acid pH that favours the antimicrobial activity of the iodine. (35)
One RCT (35) on cadexomer iodine was found. In this study, 16 patients that received treatment of pressure ulcers using daily application of cadexomer iodine were compared with a control group of 18 patients who received the standard treatment in their hospital, including saline dressing, enzyme-based debridement, and nonadhesive dressings. Within 3 weeks of treatment, cadexomer iodine treatment resulted in a significantly greater re-epithelialization and greater absolute and percentage reduction of ulcer area. This advantage was maintained at 8 weeks and healing was also significantly better with cadexomer iodine (8/16 vs. 1/18, P < .01). People treated with cadexomer iodine also had significantly greater reduction in pain and pus/debris compared with standard treatments. (35)
Maggot Debridement Therapy
No RCTs on maggot debridement of pressure ulcers were found. In a nonrandomized study, Sherman et al. (36) compared pressure ulcers treated with maggot debridement to those treated with only conventional therapy (Table 13). Patient allocation to maggot therapy was based on the decision of the physician and the patient. Patients in the intervention group received, in addition to conventional therapy, two 48-hour debridement treatments each week using sterile maggots. The controlled group received only conventional therapy prescribed by their primary care provider or the hospital’s wound care team, which included topical antimicrobial therapy (35%), hydrogel (10%), chemical debridement (8%), saline moistened or wet-to-dry dressings (8%), hydrocolloid and alginates (6%), growth factors (4%), and combinations of nonsurgical treatments (12%). Almost 12% of the control group also received bedside or intraoperative surgical debridement. (36)
Table 13:
Table 13:
Nonrandomized Controlled Study on Maggot Debridement Compared With Conventional Therapy*
Sherman et al. (36) reported that after 8 weeks, the rate of complete healing was higher in the maggot debridement group compared with the conventional group (RR 1.94); the difference was close to but did not reach statistical significance since the lower limit of the 95% CI overlapped with 1 (Figure 10). The percentage reduction in surface area of the wound at 4 weeks was significantly higher in the maggot debridement group (79% vs. 44%, P < .05). The average time taken to completely heal a pressure ulcer was not significantly different between the two groups (12 weeks for maggot debridement therapy vs. 13.4 weeks for the control). (36)
Figure 10:
Figure 10:
Forest Plot of Ulcers Healed – Maggot Debridement Versus Conventional Therapy*
*CI indicates confidence interval; RR, relative risk.
Devices for Debridement
Devices for debridement include syringes, dental irrigation systems, pulsed lavage systems, and high power water jet systems. The available evidence is shown in Table 14.
Table 14:
Table 14:
Studies on Devices for Debridement*
Summary of Analysis – Debridement
Table 15:
Table 15:
Impact of Debridement on Complete Healing*
Table 16:
Table 16:
Impact of Debridement on Necrotic Area or Area of Pressure Ulcer*
Summary Statements – Debridement
There was no evidence that debridement using collagenase, dextranomer, cadexomer iodine, or maggots significantly improved complete healing compared with placebo
There were no statistically significant differences between enzymatic or mechanical debriding agents with the following exceptions:
  • Papain urea resulted in better debridement than collagenase.
  • Calcium alginate resulted in a greater reduction in ulcer size compared with dextranomer.
  • Adding streptokinase/streptodornase to hydrogel resulted in faster debridement.
  • Maggot debridement resulted in more complete debridement than conventional.
  • There is limited evidence on the healing effects of debriding devices.
Expert Opinion
  • Regular debridement is necessary to convert a chronic wound to an acute wound in order to initiate healing.
  • Surgical debridement is the most effective debridement technique especially in pressure ulcers with much necrosis.
  • Enzymatic debridement and autolytic debridement are slow and are only effective in wounds with minimal necrosis. They can be used in adjunct to surgical debridement.
Topical Agents
Topical Phenytoin Versus Traditional Dressing or Advanced Dressing
Phenytoin is an antiepileptic agent. Topically applied, phenytoin has been shown to accelerate the healing process in ulcers of various etiology. (39) Proposed actions of phenytoin include accelerated fibroblast proliferation, formation of granulation tissue, deposition of connective tissue components, reduction in collagenase activity, and bacterial contamination of the ulcer. (40) A common and frequent adverse effect of phenytoin sodium anticonvulsant therapy is gingival hyperplasia.
The review update found two studies that explored the efficacy of topical phenytoin treatment on pressure ulcers (Table 17). Hollisaz et al. (41) compared a hydrocolloid dressing to phenytoin cream and a simple saline dressing in an 8-week randomized controlled study. Hydrocolloid dressing resulted in a higher percentage of complete healing only in stage I ulcers compared with phenytoin cream (85% vs. 22%, P < .005), whereas in stage II ulcers the difference in percent complete healing between phenytoin cream and hydrocolloid dressing did not reach statistical significance (67% vs. 48%, P > .05).
Table 17:
Table 17:
Randomized Controlled Trials Comparing Topical Phenytoin With Traditional or Advanced Dressing*
Subbanna et al. (40) compared stage II pressure ulcers treated for 15 days with sterile gauze soaked in a phenytoin solution with pressure ulcers treated with saline gauze. At the end of the 15 days, no statistically significant differences were detected between the two groups in the reduction in PUSH scores (19.53 vs. 11.39, P = .261), reduction in the size of the ulcers (47.83% vs. 36.03%, P = .132), or in reduction of volume (53.94% vs. 55.76%, P = .777). No patients withdrew because of adverse events.
Pooling the two studies was not appropriate or feasible because of differences in patient populations, comparators, and reported outcomes.
Topical Collagen Versus Hydrocolloid Dressing
In a single-blind RCT, Graumlich et al. (11) compared 35 stage II and III pressure ulcers treated with topical collagen to 30 pressure ulcers treated with hydrocolloid dressing (Table 18). There were no statistically significant differences in age, area and depth of ulcers, stage of ulcers, or duration of ulcers at randomization. After 8 weeks of treatment, no significant differences in complete healing (Figure 11), area healed per day, or in time required to achieve complete healing could be detected between the study groups. However, collagen was applied daily compared with two changes of hydrocolloid dressing per week. The average cost per patient was higher in the collagen group compared with the hydrocolloid group ($627.56 vs. $222.36 US).
Table 18:
Table 18:
Randomized Controlled Study – Topical Collagen Versus Hydrocolloid*
Figure 11:
Figure 11:
Forest Plot of Pressure Ulcers Healed – Topical Collagen Versus Hydrocolloid Treatment*
*CI indicates confidence interval; RR, relative risk.
Dressings
As described in an earlier section, wound healing is a complex and progressive systemic process. The dressing used on the wound should intensify the body’s natural response to wound healing and utilize its own enzymes to augment healing. (42)
The choice of dressing needs to be tailored to the characteristics of the pressure ulcer such as size, stage, depth/undermining, amount of exudate or eschar, and presence or absence of infection.
Primary dressings (including beads, powder, gels, cream, and bordered dressings) are placed in or on the wound surface. If the primary dressing does not have an adhesive border, then a secondary cover dressing is used to secure the primary dressing. Secondary dressings are designed to provide additional support, absorption, compression, and protection, when needed.
Traditional dressings include gauze moistened with saline (wet-to-dry or wet-to-wet) and paraffin impregnated gauze.
Major types of advanced dressing include hydrocolloid, polyurethane foam, hydropolymer, hydrocellular, and alginate. The characteristics of the various dressings are summarized in Table 19.
Table 19:
Table 19:
Characteristics of Major Types of Dressings
Hydrocolloid
Polyurethane Foam: The polyurethane foam dressing consists of a soft foam sheet with a hydrophilic wound contact surface that has low adherence. The middle portion of the dressing consists of hydrophilic foam that absorbs and contains the exudate. The foam backing layer is moisture-vapour permeable but impermeable to water and bacteria. (43)
Hydropolymer: Hydropolymer adhesive dressings (TIELLE, Johnson and Johnson) consisting of a polyurethane adhesive backing, a centre hydropolymer island, and a nonwoven layer in between. As the dressing absorbs exudate, the hydropolymer central island swells and fills any irregular contours to the wound, minimizing exudate build-up and the chance of maceration. Excess moisture is held in the wicking layer next to the polyurethane backing. The vapour-permeable backing allows excess moisture to evaporate through the back of the dressing, allowing the dressing to manage additional exudate. (44) (Thomas 1997, J of Wound Care 1997; 6(8): 1997)
Hydrocellular: The hydrocellular dressing (Allevyn Hydrocellular, Smith and Nephew Medical, Hull, England) consists of a layer of soft, hydrophilic polyurethane foam about 4 mm thick boned to semi-permeable polyurethane film. The wound contact surface is covered with apertured three-dimensional plastic net (43) This dressing is available in both adhesive and nonadhesive format. Alginate: Alginate is a dressing made from seaweed.
Existing Systematic Reviews on Efficacy of Dressings in the Treatment of Pressure Ulcers
Four systematic reviews on wound dressings were identified. These are summarized in Table 20.
Table 20:
Table 20:
Previous Systematic Reviews on Wound Dressings*
Three of the reviews (46-48) only included studies on pressure ulcers whereas one review (45) also included studies on other types of wounds. Two of the reviews (45;47) concluded that hydrocolloid was superior to gauze dressing for healing pressure ulcers and wounds. One review (48) supported the use of modern dressing. The most recent review concluded that results of comparisons between modern and traditional dressings varied and that there were no statistically significant differences between modern dressings. (46)
The MAS literature search identified five additional studies (41;49-52) on dressings that have not been included in the Royal College of Nurses (RCN) review. These studies will be reviewed along with studies included in previous reviews.
MAS Review on Dressing
Modern Dressing Compared With Traditional Dressing
Comparisons of modern dressings with traditional dressings (gauze, paraffin gauze) were performed including studies identified from previous systematic reviews and new studies from literature search. The following comparisons between advanced and traditional dressings were performed.
Advanced DressingTraditional Dressing
HydrocolloidSaline gauze
HydrocolloidGauze soaked with an antimicrobial solution
Polyurethane (moisture vapour permeable)Saline gauze
HydrogelSaline gauze
HydrogelGauze soaked with an antimicrobial solution
Comparison 1: Hydrocolloid versus Saline Gauze
Seven RCTs compared hydrocolloid with saline gauze in the treatment of pressure ulcer (Table 21). With the exception of a single study, (41) the other studies were included in the review by the RCN (46) (2005). These studies are described in Table 21 and Appendix 4
Table 21:
Table 21:
Summary of Randomized Controlled Trials Comparing Hydrocolloid With Saline Gauze*
Heterogeneity was found among the studies. Settings of the studies included long-term care facilities, community care, and acute care. Most of the patients were elderly with the exception of one study that was conducted on patients with spinal cord injury. Six of the studies included stage II and III ulcers and one did not specify the stage of the ulcer. Duration of treatment ranged from 6 weeks to 6 months. The outcomes of these studies are summarized in Table 22.
Table 22:
Table 22:
Outcomes of Randomized Controlled Trials Comparing Hydrocolloid With Saline Gauze*
Only 5 of these studies provided data on complete healing (Alm 1989, (53) Xakellis 1992, (54) Colwell 1993, (55) Matzen 1999, (56) and Hollisaz 2004 (41)). Because the study by Xakellis (54) had much longer treatment duration compared with the other 4 studies (6 months vs. 6–12 weeks), it was analyzed separately from the other 4 studies.
The Forest plot of the studies that compared treatment with hydrocolloid dressing with treatment with gauze dressing soaked in saline solution for 6–12 weeks showed a similar trend in complete healing favouring hydrocolloid. The use of hydrocolloid dressing increased the likelihood of complete healing by almost three-fold compared with saline gauze dressing (RR 2.84 [95% CI, 2.30–6.41], P < .00001). The test for heterogeneity was not significant (I2 = 0%, P = .46) (Figure 12). Most of the studies also showed a greater reduction in the mean surface area of the ulcer in the hydrocolloid-dressing group compared with the saline gauze group.
Figure 12:
Figure 12:
Forest Plot of Ulcers Healed – Hydrocolloid Dressing Versus Saline Gauze (6–12 Weeks Treatment)*
*CI indicates confidence interval; RR, relative risk.
The study (54) that compared 6-month treatment with hydrocolloid dressing to 6-month treatment with saline gauze showed a similar proportion of complete healing at the end of the treatment period (RR 1.04, 95% CI [0.82–1.32], P = .77) (Figure 13). Besides having longer duration in treatment, it should be noted that the mean surface area of the ulcers at baseline was smaller (< 1 cm2) than those in the other studies.
Figure 13:
Figure 13:
Forest Plot of Ulcers Healed – Hydrocolloid Dressing Versus Saline Gauze (6 Months Treatment)*
*CI indicates confidence interval; RR, relative risk.
Comparison 2: Hydrocolloid versus Gauze Soaked in an Antimicrobial Solution
Two studies compared treatment with hydrocolloid dressing with treatment with gauze dressing soaked in povidone (Table 23). A third study that compared hydrocolloid with gauze soaked in Dakin’s solution was excluded because allocation to treatment arms was not randomized. Based on the 2 included studies (59), it appears that the advantage of hydrocolloid dressing over gauze dressing in promoting complete healing was lost when the gauze dressing was soaked in povidone. A Forest plot of the 2 studies showed no statistically significant difference in proportions of ulcers healed between the 2 treatments (RR 0.99, 95% CI [0.71–1.37], P = .94). Test for heterogeneity was not significant (I2 = 0%, P = .56) (Figure 14).
Table 23:
Table 23:
Randomized Controlled Studies Comparing Hydrocolloid Dressing With Povidine-Soaked Gauze*
Figure 14:
Figure 14:
Forest Plot of Ulcers Healed – Hydrocolloid versus Gauze Soaked in Antiseptic Solution*
*CI indicates confidence interval; RR, relative risk.
Comparison 3: Polyurethane (Moisture Vapour Permeable) Dressing versus Saline Gauze
Sebern et al. (60) compared a transparent moisture vapour permeable (MVP) polyurethane adhesive dressing with gauze moistened with saline in home care patients with grade 2 or 3 pressure ulcers. The RCT compared 37 pressure ulcers treated with MVP and 40 pressure ulcers treated with saline gauze dressing (Table 24).
Table 24:
Table 24:
Randomized Controlled Study Comparing Polyurethane Dressing With Saline Gauze*
At the end of the 8-week treatment, no significant difference in complete healing or median percent reduction in surface area was found between the study groups, though complete healing of grade 2 ulcers was significantly higher in the MVP treated group compared with the saline gauze group. Notably, the sample size was small and there is much uncertainty about the point estimate in the meta-analysis because of the wide CI (Figure 15). The median percentage reduction in surface area was also significantly higher in grade 2 ulcers treated with MVP compared with grade 2 ulcers treated with gauze dressing (100% vs. 52%, P < .01). The authors concluded that MVP dressing improved the rate of healing in the treatment and was more cost effective in the treatment of grade 2 pressure ulcers, but there was no significant difference in the healing rate or cost for the grade 3 ulcers.
Figure 15:
Figure 15:
Forest Plot Comparing Healing of Grade 2 Pressure Ulcers – Polyurethane Dressing Versus Saline Gauze*
*CI indicates confidence interval; RR, relative risk.
Comparison 4: Hydrogel versus Gauze
Two studies compared hydrogel with gauze dressing. These are summarized in Table 25.
Table 25:
Table 25:
Randomized Controlled Trials Comparing Hydrogel With Saline Gauze*
Thomas et al. (62) compared hydrogel derived from the aloe plant with gauze moistened with saline solution in 41 elderly nursing home residents and home care recipients with stage II to stage IV pressure ulcers with surface area equal to or greater than 10 cm2. After 10 weeks treatment, 11 patients dropped out because of death, ulcer deterioration, hospitalization, or protocol violation. Analysis based on the 30 remaining ulcers showed no statistically significant differences in complete healing of ulcers (RR 0.97, 95% CI [0.56–1.68)] (Figure 16). The average time needed to achieve complete healing was also similar between the 2 treatment groups (5.3 weeks for hydrogel vs. 5.2 weeks for gauze). (62)
Figure 16:
Figure 16:
Forest Plot of Ulcers Healed – Hydrogel versus Traditional Dressing*
*CI, confidence interval; RR, relative risk.
A more recent study by Kaya et al. (63) compared an occlusive hydrogel-type dressing with gauze soaked in povidone-iodine in the treatment of 49 stage I to stage III pressure ulcers in 27 patients with spinal cord injury. Kaya et al. (63) reported that the rate of healing was not significantly different between the two treatment groups (0.12 [SD 0.16] cm2/day for hydrogel vs. 0.09 [SD 0.05] cm2/day for povidone-iodine gauze, P = .97); however, the percentage of ulcers that have epithelialized was significantly higher in the hydrogel group (Figure 17). This difference was marginal since the lower limit of the 95% CI was very close to 1.
Figure 17:
Figure 17:
Forest Plot of Percent Epithelialization – Hydrogel versus Gauze Soaked in Providone Iodine*
*CI indicates confidence interval; RR, relative risk.
Modern Dressing Compared With Modern Dressing
Studies were available for the following comparisons between advanced dressings (Table 26).
Table 26:
Table 26:
Comparisons of an Advanced Dressing With Another Advanced Dressing
Comparison 1: Hydrogel Dressing versus Hydrocolloid Dressing
Hydrocolloid and hydrogel are two commonly used modern dressings. Three randomized studies compared hydrogel with hydrocolloid in the treatment of stage II to III pressure ulcers (see Table 27)
Table 27:
Table 27:
Hydrogel Dressing Versus Hydrocolloid Dressing*
Darkovich et al. (76) compared BioFilm® hydrogel dressing (BF Goodrich Company; now known as Flexigel®, Smith and Nephew, Largo, Florida) with the DuoDERM® hydrocolloid dressing (Bristol-Myers Squibb, Princeton, New Jersey) in the healing of grade 1 (ulceration or skin breakdown limited to superficial epidermis and dermal layer) and 2 ulcers (ulceration extending through the dermis but not through adipose tissue) based on the Enis and Sarmienti classification system (equivalent to stage II and III in the NPUAP system). The BioFilm dressing consists of a polyurethane top film and foam bonded to a fabric containing the hydrogel with an adhesive on the underside. DuoDERM hydrocolloid dressing is composed primarily of pectin, gelatin, and carboxymethyl cellulose. After 60 days treatment, a significantly higher proportion of pressure ulcers healed in the hydrogel group compared with the hydrocolloid group (RR 1.82 [95% CI, 1.09–3.05], P = .02) (Figure 18).
Figure 18:
Figure 18:
Forest Plot of Ulcers Healed – Hydrogel versus Hydrocolloid*
*CI indicates confidence interval; RR, relative risk.
Ninety percent of the ulcers in the hydrogel group healed or improved compared with 78% in the hydrocolloid group. Mean percent of wound area healed was 68% in the hydrogel group and 40% in the hydrocolloid group. The difference in the percent of area healed between the 2 groups was not significant for stage I ulcers, but the mean percent of area healed was significantly higher for stage II wounds treated with hydrogel (64% vs. 34%, P < .025). (76)
Two randomized studies compared sheet hydrogel dressing with hydrocolloid dressing in the healing of stage II and III pressure ulcers. Motta et al. (64) compared the AcryDerm polymeric sheet wound dressing (AcryNed, Portland, Oregon) with the DuoDerm CGF hydrocolloid dressing in 10 patients. Standardized wound care included light debridement, cleansing, and sterile saline irrigation as required before the application of the dressing. After 8 weeks of treatment, complete healing occurred in 2 out of 5 patients in each group. The overall healing rates of ulcers from the study groups were not significantly different and no significant differences were noted between the dressing performances, with the exception that the use of the polymeric hydrogel dressing was more often associated with desirable levels of autolytic debridement than the hydrocolloid dressing.
Mulder et al. (57) also compared a Clearsite hydrogel sheet dressing (New Dimensions in Medicine, Dayton, Ohio) with a DuoDERM hydrocolloid dressing (ConvaTec/Bristol Myers-Squibb, Princeton, New Jersey) and wet-to-moist gauze dressing in a multisite randomized study. Clearsite is composed mainly of water, plasticizer/humectant, and propylene glycol, and has an adhesive border. After 8 weeks treatment, the median and mean percentage change per week in wound surface area of stage II and III ulcers was not significantly different between the hydrogel and the hydrocolloid groups [weighted mean difference:– 4.70 (95% CI, 19.37–9.97), P = .53] (Figure 19). No data on complete healing of pressure ulcers were reported and there were no significant differences in qualitative outcomes. The transparency of the hydrogel sheet dressing allowed visualization of the wound through the dressing.
Figure 19:
Figure 19:
Percent Change per Week in Surface Area of Ulcer – Hydrogel Versus Hydrocolloid*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
A Forest plot of ulcers healed showed a statistical significant difference in ulcers treated with hydrogel compared with hydrocolloid [RR 1.71, (95% CI, 1.05–2.79), P = .03] (Figure 20).
Figure 20:
Figure 20:
Forest Plot of Ulcers Healed – Hydrogel Dressing Versus Hydrocolloid Dressing*
*CI indicates confidence interval; RR, relative risk.
Comparison 2: Polyurethane Foam Dressing Versus Hydrocolloid Dressing
Three randomized studies compared polyurethane foam dressing with hydrocolloid dressing in the healing of stage II and III pressure ulcers (summarized in Table 28). The studies were small with the number of ulcers ranging from 29 to 60. Two were performed in hospitals and one in a community setting. Methodological limitations included no concealment of allocation, no a priori power calculation, lack of blinded outcome assessment, and lack of intention-to-treat analysis despite high withdrawal rates.
Table 28:
Table 28:
Polyurethane Dressing Versus Hydrocolloid Dressing
Bale et al. (66) (1997) compared the performance of the Allevyn® Adhesive polyurethane foam dressing to the Granuflex® hydrocolloid dressing (ConvaTec, Bristol-Myers Squibb, UK). The Granuflex dressing consisted of a semi-permeable polyurethane film bonded to a wound contact surface coated with a hydrocolloid matrix. The patient groups were balanced for age, sex, and stage and site of pressure ulcers. After 4.3 weeks of treatment, the proportion of wounds that healed between the groups was not significantly different [RR 1.50, (95% CI, 0.53–4.19)]. Both had similar ease of application and wear time, but the polyurethane foam dressing was found to conform better to the wound and have better absorbency and hence less soiled clothing (4% vs. 25%, P = .002).
Banks et al. (68) conducted two open, single-centre, randomized studies to compared the Spyrosorb® dressing (C.Y. Laboratories Ltd) with the Granuflex hydrocolloid dressing in stage II and III pressure ulcers in hospital (29 ulcers) and community settings (40 ulcers). The Spyrosorb dressing is a vapour-permeable dressing with a microporous polyurethane membrane for absorption and a pressure-sensitive wound contact surface. Both studies lasted for 6 weeks, after which no significant difference in complete healing was observed between the dressings in either the hospital or community setting.
A pooled analysis of the 3 studies yielded a RR of 1.18 in favour of polyurethane dressing, but the difference was not statistically significant [95% CI (0.85–1.64), P = .32]. The test for heterogeneity was not significant (I2 = 0%, P = .86) (Figure 21).
Figure 21:
Figure 21:
Forest Plot of Complete Healing – Polyurethane Dressing Versus Hydrocolloid Dressing*
*CI indicates confidence interval; RR, relative risk
Comparison 3: Hydropolymer Dressing Versus Hydrocolloid Dressing
Two studies compared hydropolymer dressing to hydrocolloid dressing (summarized in Table 29). Thomas et al. (44) conducted an open, 2-centre randomized trial to compare the Tielle hydropolymer dressing to the Granuflex hydrocolloid dressing in the healing of stage II and III pressure ulcers and venous leg ulcers. Only the outcomes of pressure ulcers are discussed in this review. The Tielle dressing consisted of three layers: a polyurethane adhesive backing, an absorbent island of a hydrophilic polyurethane foam, and a nonwoven fabric layer in between. No significant differences were found between dressing groups in the number of pressure ulcers that completely healed during the course of the study. Mean wear times were also not significantly different. The hydropolymer dressing was significantly more absorbent as indicated by less leakage (P = .007) and also had less difficult removal compared with the hydrocolloid dressing.
Table 29:
Table 29:
Hydropolymer Dressing Versus Hydrocolloid Dressing*
Honde et al. (69) compared an amino acid copolymer membrane dressing (Inerpan , Synthelabo) to the Comfeel hydrocolloid dressing (Coloplast) in the healing of grade 2 to 4 ulcers with a diameter less than 10 cm in 168 elderly hospital patients. There were no significant differences between the dressings in mean wear time (4.0 vs. 3.8 days) or mean number of dressings used (15 vs. 14). A higher proportion of patients treated with hydropolymer dressing achieved complete healing (RR 1.47), but this difference did not reach statistical significance (95% CI, 0.94–2.29). Ulcers treated with hydropolymer dressing achieved complete healing faster than those treated with hydrocolloid dressings (mean of 32 days vs. 38 days, P = .044).
Pooled analysis of the proportion of ulcers healed showed no statistical significant differences between polymer dressings and hydrocolloid dressings [RR 1.10, (95% CI, 0.77– 1.59), P = .59]. The test of heterogeneity showed significant heterogeneity (I2 = 77.2, P = .04) (Figure 22).
Figure 22:
Figure 22:
Forest Plot of Ulcers Healed – Hydropolymer Dressing Versus Hydrocolloid Dressing*
*CI indicates confidence interval; RR, relative risk.
Comparison 4: Hydrocellular Dressing Versus Hydrocolloid Dressing
Two randomized studies compared a hydrocellular dressing with a hydrocolloid dressing (summarized in Table 30). Bale et al. (71) compared the Allevyn hydrocellular dressing (Smith and Nephew Medical, Hull, England) with the Granuflex hydrocolloid dressing in an open-label, single-centre, randomized study. The study included stage II or III ulcers with moderate to high exudates and leg ulcers of any etiology. Only outcomes pertaining to pressure ulcers (32 out of a total of 100 ulcers) are reported in this review. Complete healing after 8 weeks was not statistically different, neither was mean wear time. The percent of dressing changes due to leakage was significantly higher with the hydrocolloid dressing and more wounds treated with hydrocolloid dressing also required cleansing at dressing change.
Table 30:
Table 30:
Randomized Studies – Hydrocellular Dressing Versus Hydrocolloid Dressing*
In another open, randomized study by Seeley et al. (70), 20 stage II or III pressure ulcers were treated with the Allevyn hydrocellular dressing and 20 were treated with the DuoDERM CGF Boarder hydrocolloid dressing (ConvaTec, Princeton, New Jersey). The ulcers in both groups were predominantly stage III ulcers (85% vs. 89%). At the end of the 8-week treatment period, there were no statistically significant differences in complete healing or in the mean reduction of ulcer area; however, the hydrocellular dressings were associated with less leakage of exudates and less difficult removals. The proportion of ulcers healed was similar for the two groups.
A meta-analysis of the two studies showed no significant differences in complete healing between the dressing groups after 8 weeks treatment (Figure 23).
Figure 23:
Figure 23:
Ulcers Healed – Hydrocellular Dressing Versus Hydrocolloid Dressing*
*CI indicates confidence interval; RR, relative risk.
Comparison 5: Sequential Calcium Alginate Dressing and Hydrocolloid Dressing Versus Hydrocolloid Alone
In a randomized study by Belmin et al. (72), 57 stage III or IV pressure ulcers were treated with UrgoSorb® calcium alginate (Urgo, France) for 4 weeks followed by the AlgoPlaque® HealthPoint hydrocolloid dressing (Urgo, France) for 4 weeks while 53 controlled ulcers were treated with the DuoDERM hydrocolloid dressing alone for 8 weeks (Table 31).
Table 31:
Table 31:
Sequential Calcium Alginate Dressing and Hydrocolloid Dressing Versus Hydrocolloid Dressing Only
After the 8-week treatment, ulcers treated with the sequential strategy showed a significantly greater mean absolute and relative reduction in the surface area compared with ulcers treated with hydrocolloid alone (Figure 24). The sequential use of calcium alginate and hydrocolloid was also associated with fewer dressings used per week, less pain during removal, and less odour. (72)
Figure 24:
Figure 24:
Absolute Reduction in Ulcer Area (cm2) – Sequential Calcium Alginate and Hydrocolloid Versus Hydrocolloid*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
Comparison 6: Antimicrobial Dressings versus Another Modern Dressing
Silver-Releasing Dressings
Two RCTs explored the effect of silver-releasing dressings on chronic wounds at high risk of infection, including pressure ulcers (Table 32). Pressure ulcers constituted 29% and 7%, respectively, of the study populations (49;50).
Table 32:
Table 32:
Randomized Controlled Studies Comparing Silver-Releasing Advanced Dressing Compared With Another Modern Dressing in Standard Practice*
Meaume et al. (49) reported that pressure ulcers treated with a silver-releasing alginate dressing appear to have a greater wound reduction after 4 weeks (31.6% vs. 13.9%) and greater reduction in wound severity score (30.7% vs. 17.5%) compared with ulcers treated with an alginate dressing. No statistical analysis can be performed, however, because of the small sample sizes (statistical significance is, therefore, also unknown). Munter et al. (50) found that at the end of 4 weeks of treatment, the silver-releasing foam dressing had greater reduction in ulcer area (58.5% vs. 33.3%), less maceration, better exudate handling, and faster reduction of malodour compared with dressings in standard practice. However, the sample was too small to perform statistical analysis. The mean wear time was significantly longer for silver-releasing foam dressing (3.1 days vs. 2.1 days, P < .0001).
Topical Honey Dressing
There is growing interest in using honey as a wound dressing material. Clinical studies in other types of wounds (e.g. leg ulcers) suggest that honey may facilitate wound healing by providing a moist healing environment, preventing excessive bacterial growth, and by reducing inflammation, pain, and swelling. (51)
Gunes et al. (51) studied the effect of dressings with unprocessed honey on the healing of Stage II and III pressure ulcers. Twenty-five ulcers in 15 patients treated with honey dressing were compared with 25 ulcers (11 patients) treated with nitrofurazone cream and gauze soaked with ethoxydiaminoacridine solution. At the end of 5 weeks, the honey-treated ulcers had significantly lower ulcer severity scores (6.55 vs. 12.62, P < .001), four times the rate of pressure healing (56% decrease in ulcer size vs. 13%, P < .001), and a higher percentage of completely healed ulcers (20% vs. 0%, P < .05). Yapacu et al. suggested that additional studies are required to compare honey dressing with alginate, hydrocolloid, and hydrogel dressings, and in patients with stage IV ulcers.
Comparison 7: Noncontact Normothermic Dressing/Radiant Heat Dressing Versus Modern Dressings
Applying heat to local wounds has been shown to increase capillary flow by 3-fold, increase tissue oxygen tension, and reduce the growth of bacteria. (73) It has been suggested that preventing hypothermia and maintaining a normothermic state in a pressure ulcer might improve wound healing (52). Noncontact normothermic wound therapy using a noncontact sterile dressing and a warming unit that gives constant radiant heat at 38°C to restore periwound and wound temperatures toward normothermia. Therapy consisted of three 1-hour treatments daily.
Four RCTs compared thermal wound therapy with moisture retentive modern dressings in the treatment of stage III and IV pressure ulcers. (73);(74);(75)) Two of the studies used noncontact normothermic dressing as the heat source (73;75), while the other two studies (52;74) used radiant heat dressings. Sample size ranged from 29 to 41 patients. Two of the studies included a variety of moisture retentive dressings in the control group (73-75), whereas Thomas et al. (52) limited the comparison to hydrocolloid dressing with the addition of alginate filler as needed. The duration of the studies ranged from 8 to 12 weeks. (Table 33) None of the studies reported blinding of the assessor and only 1 of the studies reported intention-to-treat analysis.
Table 33:
Table 33:
Studies on the Use of Thermal Dressings to Treat Stages III and IV Pressure Ulcers*
Meta-analysis showed that there is no statistically significant difference in the proportion of ulcers healed between groups at the end of the study period, [RR 1.29 (95% CI, 0.84–1.97, P = .24)] (Figure 25). Although there is no significant difference in the number of wounds healed, Price et al.(75) and Kloth et al., (73) reported greater reduction is surface area (by 140% and 40% respectively) in the thermal dressing group compared with the control group. Whitney et al. (74) reported that the liner rate of healing was 0.012 (SD 0.008) cm per day for normothermic patients compared with 0.004 (SD 0.006) cm per day for control patients (P = .01), but the 95% CI of the two rates overlapped.
Figure 25:
Figure 25:
Ulcers Healed: Noncontact Normothermic Dressing Compared With Moisture Retentive Dressing*
*CI indicates confidence interval; RR, relative risk.
Table 34 shows reported adverse events of noncontact normothermic therapy.
In summary, thermal dressings such as noncontact normothermic dressings or radiant heat dressings were associated with greater improvement in stage III and IV pressure ulcers; however, this did not translate into more wound closure. There is no evidence at present to conclude that thermal dressings will result in more complete healing in stage III or IV pressure ulcers.
Table 34:
Table 34:
Reported Adverse Events of Thermal Dressings*
Summary of Analysis – Dressings
Findings of the analysis are summarized in Tables 35 through through3838.
Table 35:
Table 35:
Summary of Findings on Complete Healing – Modern Dressings Versus Traditional Dressings*
Table 38:
Table 38:
Summary on Absorbency and Ease of Removal – Modern Dressings Versus Modern Dressings*
Table 36:
Table 36:
Summary of Findings on Complete Healing – Modern Dressings Versus Modern Dressings*
Table 37:
Table 37:
Summary of Reduction in Ulcer Size – Modern Dressings Versus Modern Dressings*
Summary Statements – Dressings
  • Hydrocolloid dressing was associated with almost 3 times more complete healing compared with saline gauze.
  • There is evidence that hydrogel and hydropolymer may be associated with 50% to 70% more complete healing of pressure ulcers than hydrocolloid dressing.
  • No statistically significant differences in complete healing were detected among other modern dressings.
  • There is evidence that polyurethane foam dressings and hydrocellular dressings are more absorbent and easier to remove than hydrocolloid dressings in ulcers with moderate to high exudates.
  • In deeper ulcers (stage III and IV), the use of alginate with hydrocolloid resulted in significantly greater reduction in the size of the ulcers compared with hydrocolloid alone.
  • Studies on sustained silver-releasing dressings demonstrated a tendency for reducing the risk of infection and promoting faster healing, but the sample sizes were too small for statistical analysis and for drawing firm conclusions.
Integrating Findings on Dressings With Expert Panel Input
  • No single dressing can meet the needs of all pressure ulcers.
  • Dressings need to provide a moist environment and selection depends on:
    • An assessment of the ulcer: size, depth, amount of exudate, amount of necrotic tissue and eschar, and signs of infection (malodour, bacterial load). Adjust selection as condition of ulcer changes.
    • Staffing: gauze dressings – changed 2–3 times per day; modern dressing – changed every > 4 days.
    • Cost – Modern dressings more costly than gauze; antimicrobial dressing even more so.
  • An example of a guide for the selection of dressings based on characteristic of the ulcer, evidence, and Expert Panel input is shown in Table 39.
    Table 39:
    Table 39:
    Selection of Dressings
Biological Therapies
Topical Growth Factors
Growth factors are cytokines (chemical signals) that control cell growth, cell migration, matrix production, enzyme expression, and differentiation. They play fundamental roles in the wound repair process. Most growth factors are multifunctional and the roles of some growth factors in promoting healing of chronic pressure ulcer have been explored. The origin and mode of action of these growth factors are summarized in Table 40.
Table 40:
Table 40:
Growth Factors Studied in the Healing of Pressure Ulcers
The RCN review identified 7 small clinical trials comparing different topical growth factors to placebo 4 of which are included in this review (see Table 41). No new studies were found since the RCN review.
Table 41:
Table 41:
Studies Comparing Topical Growth Factor With Placebo in Treating Pressure Ulcers*
Platelet-Derived Growth Factor
Platelet-derived growth factor is a dimeric protein composed of two disulfilde-linked polypeptide chains. It exists in three different isoforms, the heterodimer PDGF-AN (consisting of an A chain and a B chain), and two homodimers, consisting of 2 A chains (PDGF-AA) or 2 B chains (PDGF-BB). PDGF-BB has been shown in preclinical and clinical studies to promote the formation of granulation tissues at the wound site and to stimulate wound healing. (79) Becalpermin is a recombinant PDGF-BB produced using recombinant DNA technology and formulated in a sodium carboxymethycellulose-based gel for topical administration. This preparation was used in two clinical studies on pressure ulcers. (78;79)
Mustoe et al. (78) compared a placebo group with a group of elderly patients treated in a hospital or nursing home with either 100 µg/mL or 300 µg/mL of topical platelet-derived growth factor (rhPDGFBB). At the end of the treatment period, patients in both rhPDGF-BB groups had smaller ulcer volumes compared with the placebo group (P = .009, 2-sided t-test), but the number of ulcers healed and the time to achieve 50% healing were not significantly different between the study groups. It was also reported that 14.3% of the ulcers in the placebo group healed during treatment but recurred during follow-up.
Rees et al. (79) also compared a group of patients with chronic pressure ulcers treated with a placebo gel to 3 groups treated with topical rhPDGF (becalplemin) (100 µg/mL or 300 µg/mL once daily, or 100 µg/mL twice daily). Once daily rhPDGF treatment at concentrations of 100 µg/g and 300 µg/g significantly increased the incidence of complete healing (23% vs. 0%, and 19% vs. 0%, respectively) and of > 90% healing (58% vs. 29%, and 59% vs. 29%, respectively). Treatment with rhPDGF at a concentration of 100 µg/g once daily was equally efficacious as treatment with rhPDGF at a concentration of 300 µg/g. There was no significant difference in the incidence of complete healing or ≥ 90% healing between the group treated with 100 µg/g rhPDGF twice daily and the placebo group. Kallianinen et al. (83) conducted a follow-up analysis at 1 of the study sites on patients who underwent salvage surgery after failing to heal. The analysis compared post-surgery healing rates of 3 unhealed ulcers in the placebo group with 12 unhealed ulcers that had previously received some rhPDGF treatment. Statistical analysis showed that a greater proportion (11/12) of the ulcers of patients who were treated with rhPDGF (any dose) and salvage surgery healed completely compared with placebo and salvage surgery (0/3) (P < .05). There were no significant differences in wound healing noted between different dosages of rhPDGF. (83)
Pooled analysis of above studies showed different trends in complete healing and no significant difference in healing between the rhPDGF and placebo arms at either at dosing concentration (Figures 26--2828).
Figure 26:
Figure 26:
Forest Plot of Complete Healing – Recombinant Platelet-Derived Growth Factor (100 µg/ml) Versus Placebo at 4 Weeks*
*CI indicates confidence interval; PDGF, Platelet Derived growth factor;
Figure 28:
Figure 28:
Forest Plot of Complete Healing (100 µg/ml BID) Versus Placebo at 4 Weeks* Recombinant Platelet-Derived Growth Factor
*BID indicates twice daily; CI, confidence interval; GF, growth factor; RR, relative risk.
Figure 27:
Figure 27:
Forest Plot of Complete Healing (300 µg/ml) Versus Placebo at 4 Weeks* Recombinant Platelet-Derived Growth Factor
*CI indicates confidence interval; PDGF, Platelet Derived growth factor
Safety of Platelet-Derived Growth Factor
On March 27, 2008, the US FDA (84) issued a communication regarding the safety of Regranex, a recombinant PDGF approved for the treatment of diabetic leg ulcer. The FDA communication stated that a long-term safety study by the manufacturer completed in 2001 reported more cancers in people who used Regranex (recombinant PDGF) than in those who did not use it. In addition, an analysis of a health insurance database (1998–2003) showed that deaths from cancer (all types combined) were higher for patients who were given ≥ 3 prescriptions for Regranex than those who were not treated with Regranex. The FDA urges health care professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch. (84)
Fibroblast Growth Factor and Granulo Macrophage Colony-Stimulating Factor
Robson et al. (80) compared patients treated sequentially with granulocyte macrophage colony-stimulating growth factor (GM-CSF) and basic fibroblast growth factor (BFGF) with patients treated with each of the growth factors alone, and with patients treated with a placebo. The mean change in volume of the pressure ulcers at 35 days did not differ significantly among the groups. At 6 weeks, 50% of the 44 patients treated with growth factor achieved complete closure of the ulcer compared with 3 out of 13 patients treated with placebo. This difference did not achieve statistical significance. Payne et al. (81) reported that at 1-year follow-up there were no significant differences among the percentage of patients healed across the four treatment groups at any follow-up visit (P > .05) (Figures 29--31).31). There was a trend for BFGF treated patients to achieve healing faster than the other groups, but the difference did not reach statistical significance (log-rank P = .18, Wilcoxon P = .25)
Figure 29:
Figure 29:
Forest Plot of Complete Healing – Fibroblast Growth Factor Versus Placebo at 6 Weeks*
*CI indicates confidence interval; FGF, fibroblast growth factor; RR, relative risk.
Figure 31:
Figure 31:
Forest Plot of Sequential Fibroblast Growth Factor and Granulo Macrophage Colony Stimulating Factor Versus Placebo at 6 Weeks*
*CI indicates confidence interval; FGF, fibroblast growth factor; GMCSF, granulo macrophage-colony stimulating factor; RR, relative risk.
Figure 30:
Figure 30:
Forest Plot of Complete Healing Versus Placebo at 6 Weeks* Granulo Macrophage Colony Stimulating Factor
*CI indicates confidence interval; GM-CSF, granulo macrophage-colony stimulating factor; RR, relative risk.
Nerve Growth Factor
Nerve growth factor is a polypeptide that has been shown to promote the regeneration of injured cells that express nerve growth factor receptors in the peripheral and central nervous systems. Observational studies suggest that nerve growth factors speeded recovery from skin ulcer in humans. (82)
Landi et al. (82) compared 18 patients with pressure ulcers of the foot randomly assigned to receive topical nerve growth factor daily for 6 weeks with 18 patients assigned to receive a balanced salt solution (vehicle control) without nerve growth factor. The pressure ulcers healed completely in 8 patients in the nerve factor treated group compared with 1 patient in the control group (Figure 32). None of the ulcers in the control group improved by 3 stages or more during the treatment period.
Figure 32:
Figure 32:
Forest Plot of Complete Healing – Nerve Growth Factor Versus Placebo at 6 Weeks*
*CI indicates confidence interval; RR, relative risk.
In addition to the above studies, Hirchberg et al. (85) reported on a subset analysis of data from a randomized, blind, parallel, placebo controlled trial involving 14 patients with stage III or stage IV ulcers located on the trunk. The analysis compared patients who received topical recombinant transforming growth factor (TGF-(33) (1 µg/cm2 or 2.5 µg/cm2) with patients who received topical placebo. Patients who received 2.5 µg/cm2 of TGF-(33 exhibited an increased rate of wound healing at the fourth visit (P < .05), but there was no significant difference in the healing rate among the groups at the end of the 16-week follow-up period. No conclusion can be drawn from this study because of its small sample size (14) and high attrition (43%).
A pooled analysis was performed that included the four studies with available data. The analysis compared complete healing in patients that received any growth factor with patients that received placebo. The results showed an RR of 2.29 in favour of growth factors; however, this did not reach statistical significance (95% CI, 0.52–9.98), and the test for heterogeneity showed much heterogeneity (I2 = 64.2%) (Figure 33). Note that in the figure below, that the study by Mustoe et al. (78) had the shortest treatment period (4 weeks) which may explain its deviation in results from the other studies.
Figure 33:
Figure 33:
Forest Plot of Complete Healing – Growth Factor Versus Placebo (All Studies)*
*CI indicates confidence interval; RR, relative risk.
Payne 2001 (81) – Complete healing at 6 weeks.
Engineered Skin Equivalents and Skin Matrix
Besides having decreased growth factors, chronic wounds may have impaired cell migration and insufficient angiogenesis to support complete wound closure. There may be an imbalance of matrix metalloproteases and their inhibitors, favouring tissue destruction. Cellular therapies being investigated include autologous epidermis, allografts, and engineered living skin equivalents and skin matrix. Autografts involves having a patient’s own skin removed from one area of the body and applied to the wound and can be partial or full thickness. Heterografts are tissues derived from an external source and applied to another (e.g., bovine skin or cadaver skin as a temporary covering). (Woo 2007, Advances in Skin and Wound Care, Feb, 2007)
Tissue engineering aims to develop biological substitutes or synthetic skin equivalents that emulate normal skin functions to accelerate wound healing. An example is Apligraf, a composite bilayer product that uses a combination of bovine type I collagen gel and living neonatal fibroblasts from neonatal foreskin as the dermal component, with a cornified epidermal layer of neonatal keratinocytes. (86)
Dermal substitutes made from collagen matrix have also been investigated as artificial dermis in the treatment of deep wounds.
No randomized controlled studies were found on the use of engineered skin substitutes and skin matrix to treat pressure ulcers, although two observational studies were identified (Table 42).
Table 42:
Table 42:
Studies in Engineered Skin Substitute and Skin Matrix
Ichioka et al. compared 9 patients with stage IV sacral ulcers treated with a collagen matrix substitute dermis (Terudermis, Terumo Corp., Tokyo, Japan) to 6 patients with grade 4 sacral ulcers treated with alginate dressing instead of Terudermis. Terudermis consists of an atelocollagen matrix with a silicone layer that acts as a scaffold for regeneration. Ulcers from both groups were thoroughly debrided and cleansed before treatment. After an average follow-up period of 31.2 months (SD 2.6, range 20–44 months), time to achieve complete epithelialization was significantly shorter in patients that received the substitute dermis compared with the conventional group (84.1 days vs. 215.3 days). Histological examination of the substitute dermis group showed a significant increase in post-treatment area vascular density (431.9% of pre-treatment density) and in length density (1,059% of pre-treatment density) Brem et al. (87) treated 21 consecutive patients with stage III or IV pressure ulcers with Apligraf. After one application of Apligraf, 62 % of the patients achieved complete healing of the ulcer in a mean healing time of 29 days. Ichioka et al. (88) reported a nonrandomized study that found much shorter time to epithelialization and greater increase in vascular density in patients given a collagen matrix substitute compared with patients treated with conventional therapy.
Summary of Analysis – Biological Therapies
Table 43:
Table 43:
Summary of Impact of Biological Therapy on Complete Healing of Pressure Ulcers*
Summary Statements – Biological Therapies
  • The efficacy of growth factors in improving complete healing of chronic pressure ulcers has not been established.
  • Presently only Regranex, a recombinant PDGF has been approved by Health Canada and only for treatment of diabetic ulcers in the lower extremities.
  • A March 2008 FDA communication reported increased deaths from cancers in people given 3 or more prescriptions for Regranex.
  • Limited low quality evidence on skin matrix and engineered skin equivalent suggests a potential role for these products in healing refractory advanced chronic pressure ulcers, but the evidence is insufficient to draw a conclusion.
Pressure-Relieving Support Surfaces
Support surfaces include special beds, mattresses replacements, mattress overlays, and seat cushions.
Classification of Pressure-Relieving Support Surfaces
Low Tech Devices
  • Standard foam mattresses
  • Alternative foam mattresses: high specification foam mattress (defined as a foam mattress with a two-way stretch vapour permeable cover), viscoelastic, convoluted foam, cubed foam
  • Gel-filled, fluid-filled, fibre-filled, and air-filled mattresses and overlays
Constant Low-Pressure Devices
  • Air-fluidized therapy: consist of a bed frame containing silicone-coated beads. This type of bed uses both air and fluid to provide support. Beads in the bed behave like a liquid when air is pumped through them. On this type of bed, the body is immersed in the warm, dry fluidized beads. Air-fluidized beds are recommended for patients with multiple large pressure ulcers. They are not recommended for patients with pulmonary disease or unstable spines or for patients who are ambulatory. Because so much air is needed to fluidize the total bed, dehydration (from heat escaping from the body) is a risk.
  • Low- air-loss beds: patients are supported on air-filled sacs inflated at a constant pressure, through which air can pass.
  • Air-fluidized and low-air-loss (LAL) beds are designed to conform to the body contours. In addition to providing pressure relief, these specialty beds also eliminate shear and friction and, decrease moisture.
Alternating Pressure Systems
  • Alternating pressure (AP) mattress overlays
  • AP mattress replacements
  • Turning beds/frames (kinetic or profiling beds): beds that either aid manual repositioning of the patient or reposition the patient by motor-driven turning and tilting
Previous Systematic Reviews on Pressure-Relieving Support Surfaces
Three previous systematic reviews examined the evidence on pressure relieving support surfaces as treatments for pressure ulcers (Table 45). These reviews found some evidence that air-fluidized beds may improve the rate of healing of pressure ulcers compared with AP beds or mattresses, but found no conclusive evidence on the influence of other beds and surfaces on the healing of pressure ulcers.
Table 45:
Table 45:
Systematic Reviews on Pressure Relieving Support Surfaces*
Table 44:
Table 44:
Classification of Pressure Relieving Devices for Pressure Ulcer Treatment
MAS Review of Evidence
The MAS reviewed the updates to the 2005 RCN review on support surfaces since it is the most current and comprehensive review available. The MAS literature search yielded 2 additional RCTs (Rosenthal 2003 and Nixon 2006). (91;92) One retrospective comparative study (93) was included because of the large sample size. A total of 16 studies were included in the analysis (Table 46). Detailed description of the studies is provided in Appendices to 4.
Table 46:
Table 46:
Studies on Support Surfaces for Treatment of Pressure Ulcers*
Comparison 1: Air-Fluidized Bed with Other Support Surfaces
Three RCTs compared the air-fluidized bed with other support surfaces (Table 47).
Table 47:
Table 47:
Randomized Controlled Trials Comparing Air-Fluidized Bed With Other Support Surfaces*
Munroe et al. (99) compared treatment of grade 2 and 3 ulcers using air fluidized bed with treatment using a standard hospital bed and sheep skin or gel pads placed underneath the ulcer. At the end of the 2-week treatment, the 20 patients that received an air fluidized bed had a 44% reduction in the surface area of the ulcer, whereas the other 20 patients that received a standard hospital bed had a 40% increase in the area of the ulcer. Mean nursing time per patient was higher in the group that used air-fluidized bed, but the increase in nursing time was not statistically significant (Figure 34).
Figure 34:
Figure 34:
Nursing Time per Patient (Minutes) – Air Fluidized Bed Versus Standard Hospital Bed*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
Two studies compared air-fluidized beds with low-pressure support surfaces. Allman et al. (98) randomized 32 patients to receive air-fluidized beds and repositioning every 4 hours and 24 patients to be given an AP air mattress covered with a 19 mm foam pad. Patients in the control group were turned every 2 hours and allowed to use heel or elbow protection. Physicians were allowed to order a plastic surgery consult, topical therapy with saline or povidone-iodine, enzymatic debridement, sterile gauze dressing, and whirlpool treatment as needed. Approximately 90% of the ulcers in each arm were stage II or higher. The proportion of patients that had either healed or improved ulcers was higher in the group that received air-fluidized beds compared with the AP air mattress, but the difference did not reach statistical significance (Figure 35). There were also no significant differences in the proportion of improved ulcers between the two arms when only ulcers equal to or larger than 7.8 cm2 were considered (Figure 36).
Figure 35:
Figure 35:
Forest Plot of Improved Ulcers – Air-Fluidized Bed versus Conventional Therapy (Hospital) All Ulcers*
*CI indicates confidence interval; RR, relative risk.
Figure 36:
Figure 36:
Forest Plot of Improved Large Ulcers (>7.8 cm2) – Air-Fluidized Bed versus Conventional Mattresses (Hospital)*
*CI indicates confidence interval; RR, relative risk.
The authors reported a mean reduction of 1.2 cm2 in the surface of ulcers in the air-fluidized bed arm compared with an increase of 0.5 cm2 in the control arm. This difference was more pronounced (-5.3 cm2 vs. +4.0 cm2) and statistically significant (P = .01) for large ulcers (≥ 7.8 cm2).
Strauss et al. (100) compared 58 home care patients that received air-fluidized beds with 54 that received other low pressure support surfaces (AP pads, air support mattresses, water filled mattresses, or high-density foam mattresses). Only patients with stage III or IV ulcers were included. Virtually all patients in both groups had moist or wet-to-dry dressing. Only 50% of the air-fluidized bed group and 56% of the control group completed the study. The proportion of improved ulcers was not significantly different between the two arms (Figure 37); however, the mean hospital stay per patient during the study was 13 days shorter for patients that received air-fluidized bed therapy (Figure 38).
Figure 37:
Figure 37:
Forest Plot of Improved Ulcers – Air-Fluidized Bed Versus Conventional Therapy*
*CI indicates confidence interval; RR, relative risk.
Figure 38:
Figure 38:
Pressure Ulcer Related Hospital Days – Air-Fluidized Bed Versus Conventional*
*CI indicates confidence interval; SD, standard deviation; WMD, weighted mean difference.
Pooled analysis of the studies showed a significantly higher proportion of improved ulcers in patients treated with air-fluidized beds compared with other low pressure support surfaces [RR 1.36, 95% CI (1.02–1.82), P = .01] and the test for heterogeneity was not significant (I2 = 0%, P = .51) (Figure 39).
Figure 39:
Figure 39:
Forest Plot of Improved Ulcers – Air-Fluidized Bed Versus Conventional (Hospital and Home Setting)*
*CI indicates confidence interval; RR, relative risk.
Ochs et al. (93) conducted a large retrospective study to compare the air-fluidized beds with other categories of support surfaces using existing data from the National Pressure Ulcer Long-Term Care Study (NPULS) in the United States (Table 48).
Table 48:
Table 48:
A Large Retrospective Study Comparing Air – Fluidized Beds, Low-Air-Loss Beds, and Static Beds
The study included 664 residents of 109 long-term care facilities that had at least 1 pressure ulcer. The 3 groups of support surfaces compared were:
Group 1: Overlays and replacement dry pressure mattresses, gel pressure pads, and air and water pressure overlays.
Group 2: Powered LAL overlays and mattresses, powered LAL-reducing beds, and AP surfaces.
Group 3: Air-fluidized beds.
There were no statistically significant differences in the mean weight among the groups, but patients in Group 3 were sicker, had significantly larger ulcers, and more stage III/IV/eschar ulcers. The analysis showed that residents in Group 3 (air-fluidized beds) had significantly greater healing rate compared with Group 1 and 2 respectively. groups (5.2 cm2/week vs. 1.5 cm2/week or 1.8 cm2/week; P = .007), particularly for stage III/IV ulcers. Patients in Group 2 had significantly more hospitalization and emergency room visits (19%) compared with Group 1 (10.2%) and Group 3 (7.3%) (P = .01).
There are limitations to this study because of the retrospective nature. Patients were not allocated randomly and there was an imbalance of sample size among the 3 groups. There were differences in the baseline characteristics of the patients and their ulcers. Moreover, due to limitation of the databases, some factors that may influence healing such as debridement, level of continence, pressure ulcer infection, effects of different dressings, and baseline nutritional status (e.g., pre-albumin level) were not available. The strength of this study is in its size since there is no prospective study on support surfaces that is close to the size of this study. (93)
Comparison 2: Low-Air Loss Mattresses With Convoluted Foam Mattresses
An LAL bed consists of multiple inflatable fabric pillows attached to a modified hospital bed frame. An electrical blower (fan) maintains comfortable buoyancy of the pillow as the heated air escapes from the fabric air sacks. This design allows subjects to assume a variety of elevated foot, knee, and head positions. Two RCTs compared LAL beds to convoluted foam mattress overlays in the treatment of pressure ulcers (Table 49).
Table 49:
Table 49:
Randomized Controlled Trials Comparing Low-Air-Loss Mattress With Convoluted Foam Mattresses
Ferrell et al. (101) compared a LAL bed and 10-inch convoluted foam mattress overlay in the treatment of stage II to IV pressure ulcers. Forty-three elderly nursing home residents were given an LAL bed while 41 residents were given the convoluted foam mattress overlay. All patients were turned every 2 hours and provided with nutritional support and infection control as needed. There were no significant differences in the stage and size of the ulcer at baseline. After a follow-up period of up to 90 days (median 33 days for LAL beds and 40 days for foam overlay), no significant differences were found in the proportion of patients with complete closure of their ulcers. Patients given an LAL bed had a significantly higher median rate of reduction in ulcer size compared with patients who received a convoluted foam overlay (median 9.0 mm2/day vs. 2.5 mm2/day). The improvement in healing rate was observed in both shallow ulcers (stage II) and in deep ulcers (stages III and IV). Cox regression modeling that adjusted for fecal continence and depth of pressure ulcer yielded a hazard ratio of 2.66 [likelihood to heal was 2.66 (95% CI, 1.34–5.17); P = .004] in favour of LAL.
In another RCT by Mulder et al. (102), 41 nursing home residents were given a LAL bed consisting of cushions that provide pulsating air suspension by alternately partially inflating and deflating cushions in the bed. Control patients (N = 18) were given a convoluted foam mattress overlay. Patients were well matched in age, nutritional status, mobility, and stage of ulcers. Ten patients were excluded from the analysis. At the end of the 12-week study period, there were no significant differences in complete healing (16% vs. 17%) or in proportion of ulcers that improved from stage IV to stage III (32% vs. 28%) (Figure 40). After adjusting for the differences in initial stage, decrease in area of the ulcer from baseline was 77% higher in the LAL group compared with the control group (P < .042), but there were no significant differences in the percentage change in volume between the groups (P = .17).
Figure 40:
Figure 40:
Forest Plot of Ulcers Improved by One Grade – Low-Air-Loss Mattress versus Convoluted Foam Mattresses*
*CI indicates confidence interval; RR, relative risk.
Day et al. also compared air suspension beds to a geometric foam mattress in 83 hospital patients with stage II to stage IV ulcers. The outcome measure was reduction in the area of the ulcer. For all ulcers, covariance analysis showed no statistically significant difference in the healing of pressure ulcers between groups. Analysis by ulcer stage showed that the proportion of stage III or IV ulcers with healing greater than 10 cm2 was significantly higher in the air-suspension bed group compared with the foam mattress overlay group.
The Forest plot of the 2 studies that reported complete healing showed no statistically significant differences in the proportions of ulcers with complete closure at 12 weeks [RR 1.25 (95% CI, 0.84–1.86); P = .27]. The test for heterogeneity was significant.
Figure 41:
Figure 41:
Forest Plot of Ulcers Completely Healed at 12 Weeks – Low-Air-Loss Beds Versus Convoluted Foam Mattresses*
*CI indicates confidence interval; RR, relative risk.
Despite a lack of statistical heterogeneity, there was clinical heterogeneity as one study included only deep ulcers (stage III and IV) whereas the other study also included stage II ulcers. There were limitations in the quality of both studies. Despite randomization in the study by Mulder et al., (102) the number of patients in the control group was about 60% of that in the LAL group. Twenty percent of patients were excluded from analysis in this study and the distribution of the excluded patients between groups was not reported. In the study by Ferrell et al., 9 patients were prematurely removed from the assigned treatment in the control group because of failure to heal in a reasonable time. (101)
In summary, the use of LAL beds was associated with greater and faster reduction in ulcer surface area but did not result in a significant improvement in complete healing of ulcers compared with treatment on convoluted foam mattress overlays.
Comparison 3: Alternating Pressure Mattress, Replacements, and Overlays
Three RCTs compared the Nimbus AP mattresses with other AP mattresses (Table 50). Two studies (94;96) compared the Pegasus AP mattresses with the Nimbus AP mattress in treating pressure ulcers (≥ stage II) in hospitals. In a 1995 RCT, Devine et al. (94) compared the healing rate of pressure ulcers in 19 patients given a Pegasus Airwave AP mattress with that of 22 patients assigned to a Nimbus I Dynamic Floatation AP mattress. The Pegasus AP mattress consists of double layers with a 3-cell alternating cycle of 7.5 minutes. The Nimbus I Dynamic Floatation AP mattress consists of rows of figure of 8 shaped cells with the two alternating sets of cell inflated and deflated over a 10-minute cycle. Standardized protocol for the use of wound dressings was reported but no details were provided. The withdrawal rate was 26% for the Pegasus group and 27% for the Nimbus group. No statistical significant differences were detected in the overall complete healing rates between the study arms after 4 weeks (Figure 42).
Table 50:
Table 50:
Randomized Controlled Trials Comparing Alternating Pressure Mattresses*
Figure 42:
Figure 42:
Forest Plot of Ulcers Healed – Airwave Alternating Pressure Mattress versus Nimbus I Alternating Pressure Mattress*
*CI indicates confidence interval; RR, relative risk.
Russell et al. (96) compared the Pegasus Cairwave AP mattress combined with the Proactive cushion to the Nimbus 3 AP mattress combined with the Aura cushion. The Nimbus 3 mattress is similar to the Nimbus I but includes 5 heel-guard cells that are powered down during deflation. One-hundred and forty-one patients completed the 18-month study but its unclear how many ulcers were included as only the number of sacral and heel ulcers were reported. Both groups achieved overall improvement of ulcers in 90% of the patients (Figure 43) and complete healing of approximately 50% of sacral ulcers (Figure 44). There were no significant differences in the length of stay or patient comfort score. The Nimbus 3 used in conjunction with the Aura cushion resulted in a significantly higher healing rate of heel ulcers compared with the Cairwave AP mattress and Proactive cushion combination (Figure 45).
Figure 43:
Figure 43:
Forest Plot of Patients With Overall Improvement in Pressure Ulcer – Cairwave Alternating Pressure Mattress Plus Proactive Cushion Versus Nimbus 3 Alternating Pressure Mattress Plus Aura Cushion*
*CI indicates confidence interval; RR, relative risk.
Figure 44:
Figure 44:
Forest Plot of Sacral Ulcers Healed – Cairwave AP/Proactive Cushion Versus Nimbus 3 AP/Aura Cushion*
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
Figure 45:
Figure 45:
Forest Plot of Heel Ulcers Healed 3 AP/Aura Cushion*
*CI indicates confidence interval; RR, relative risk.
Evans et al. (95) compared the Nimbus 3 AP mattress replacement with other AP support surfaces. Twelve patients in a hospital were randomly allocated to a Nimbus 3 AP mattress replacement or another AP mattress replacement and 20 nursing home residents were randomly assigned to a Nimbus 3 or an AP mattress overlay. The included subjects must have a grade 3 pressure ulcer or a grade 2 with impaired mobility. The same protocol for wound dressing was followed for all 4 groups. At the end of the treatment period, No significant differences were found in complete healing in either the hospital patients (3/7 vs. 0/5) or nursing home patients (0/10 vs. 4/10) (Figure 46). The median absolute or relative decrease in the area of the ulcers was not significantly different between the Nimbus 3 AP group and control group in the hospital setting or the nursing home setting.
Figure 46:
Figure 46:
Forest Plot of Healed Ulcers – Nimbus 3 Alternating Pressure Mattress Versus Another Alternating Pressure Mattress Replacement or Overlay*
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
A pooled analysis of the three studies was performed to compare complete healing on Nimbus mattresses to complete healing of another AP system in the hospital setting (Figure 47). The Forest plot showed an RR of 1.40 (95% CI, 1.08–1.80) in favour of Nimbus AP mattresses (P = .02). The test for heterogeneity is not significant (I2 = 20.2, P = .29). The advantage of the Nimbus 3 mattress appears to be mainly due to improved complete healing in heel ulcers.
Figure 47:
Figure 47:
Nimbus Alternating Pressure Mattresses Versus Another Alternating Pressure Mattress Replacement or Overlay in Hospital Setting*
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
Comparison 4: RIK Static Fluid Overlay Versus Nimbus 3 Alternating Pressure Mattresses
In another RCT, Russell et al. (97) compared the RIK mattress with the Nimbus 3 AP mattress in the treatment of pressure ulcers at stage I or higher (Table 51). The Nimbus 3 has a 10 minute cycle time, modified heel cells and is equipped with a sensor pad that continually adjusts pressure to the individual patient’s position, weight, and size. The RIK mattress is a nonpowered static fluid-filled overlay system that distributes pressure evenly by allowing the patient to sink into a fluid surface. Patients with at least a stage I pressure ulcer were randomized to receive either a Nimbus 3 AP mattress (N = 83) or to the RIK static mattress (N = 75). There were no statistically significant differences in baseline parameters. Patients in both groups were turned at least once every 4 hours. No additional pressure relieving equipment was used under any pressure area during the study. Ulcers were assessed and photographed weekly. At trial completion, the difference in ulcer improvement was not statistically significant, whether measured based on all ulcers or on the worst ulcers (Figures 48--49).49). Thirteen patients in the RIK group were transferred to a Nimbus 3 AP mattress.
Table 51:
Table 51:
Randomized Controlled Trial Comparing Nimbus 3 AP Mattresses With RIK Static Fluid-Filled Mattresses*
Figure 48:
Figure 48:
Overall Improved Ulcers – Nimbus 3 Alternating Pressure Mattress Versus RIK Static Fluid Mattresses*
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
Figure 49:
Figure 49:
Improved Worst Ulcers – Nimbus 3 Alternating Pressure Mattress Versus RIK Static Fluid Mattresses*
In summary, the Nimbus 3 AP system does not appear to be superior to other AP systems in promoting complete healing of stage II to IV pressure ulcers with the exception that it is appears to be more efficacious in healing heel ulcers. There is evidence to suggest that static fluid-filled mattresses may be as effective as a Nimbus 3 AP mattress in promoting heeling of pressure ulcers.
Comparison 5: Alternating Pressure Mattress Overlays Versus Alternating Pressure Mattress Replacements
Nixon et al. (91) conducted an open RCT that randomized 1,972 patients who were completely immobile or had very limited mobility and/or had a pre-existing grade 2 ulcer to either an AP mattress overlay (N = 989) or to an AP mattress replacement (N = 982). Patients were followed for a maximum duration of 60 days after randomization. The secondary end of this study was the number of patients with pre-existing grade 2 ulcers that healed (Table 52). At randomization, a pre-existing ulcer was present in 59 patients in the AP mattress overlay group and in 54 of the AP mattress replacement group. At the end of the study period, the existing pressure ulcer in 33.9% (20/59) in the AP mattress overlay group and 35.2% (19/54) of the AP mattress replacement group had healed. This difference is not statistically significant [RR 0.96 (95% CI, 0.58–160), P = .89] (Figure 50). Median time to healing was 20 days for both groups. The development of new grade 2 ulcers, the primary endpoint, was also not significantly different between the 2 groups (10% vs. 9.3%, P = .58). (91)
Table 52:
Table 52:
Randomized Controlled Trial Comparing Alternating Pressure Mattress Overlays With Alternating Pressure Mattress Replacements in the Treatment of Pressure Ulcers*
Figure 50:
Figure 50:
Forest Plot of Ulcers Healed – Alternating Pressure Mattress Overlay Versus Alternating Pressure Mattress Replacement
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
Comparison 6: Constant Low Pressure Mattress versus Water Mattress
Groen et al. (104) compared a constant low-pressure foam mattress replacement with a water mattress in the healing of stage III and IV pressure ulcers (Table 53). In this multicentre RCT, 60 nursing home residents were treated on the TheraRest constant low-pressure foam replacement mattress consisting of three layers of polyurethane foam with adjustable angle. Another 60 residents were given the Secutex water mattress consisting of three PVC sections, each holding 26 litres of water with heating elements (this mattress cannot be adjusted at an angle). The ulcers in both groups were treated in accordance with hospital guidelines including turning every 2 hours. At the end of the 4-week treatment period, complete healing occurred in 45% of the residents on the constant low pressure foam mattress replacement and in 48% of residents on the water mattress. The difference in healing rates did not reach statistical significance [RR 0.93, (95% CI, 0.63–1.37), P = .71] (Figure 51). (104)
Table 53:
Table 53:
Randomized Controlled Trial Comparison: Foam Mattress versus Water Mattress*
Figure 51:
Figure 51:
Forest Plot of Ulcers Healed – Constant Low Pressure Foam Mattress versus Water Mattress*
*CI indicates confidence interval; LP, low pressure; RR, relative risk.
Comparison 7: Electric Profiling Bed versus Flat-Based Beds
Electrically operated profiling beds were compared to standard flat hospital beds in one RCT examining the prevention and treatment of stage I pressure ulcers (Table 54). Keogh et al. (105) randomized 70 hospital inpatients to either the electrically operated beds (Contoura 880, Huntleigh Health Care) (N = 35) or to standard hospital beds (N = 35). A pressure reducing foam mattress was used in both groups. The standard hospital bed was a hydraulic, foot-pumped device with a flat base and a pull out backrest. Patients sitting on these beds tend to slide down the bed and often have difficulty adjusting their position or the height of the bed without help. The 4-section profiling bed facilitates the movement of patients, reducing the need for manual handling. (105) When out of bed, all patients in the study sat on a pressure-redistributing cushion or seat according to hospital policy. An existing stage I pressure ulcer was found in 4 subjects in the group that received a profiling bed and in 10 patients that received a flat-based bed.
Table 54:
Table 54:
Randomized Controlled Trials Comparing Electric Profiling Bed With Flat-Based Beds in the Treatment of Pressure Ulcers
At the end of the maximum period of 10 days, all 4 ulcers in profiling bed group and 2 in the flat-based bed groups had healed. This difference was statistically significant (RR = 5.0; P = .01), but there was much uncertainty around the RR because of the wide CI (95% CI, 1.45–17.27) as a result of the small sample size. No new grade 1 ulcers developed in either group. (105)
Figure 52:
Figure 52:
Forest Plot of Ulcers Healed – Profiling Bed Versus Flat-Based Bed*
*CI indicates confidence interval; RR, relative risk.
Comparison 8: Pressure-Relieving Seat Cushions
Three RCTs on pressure redistributing seat cushions were found. In a 1999 RCT, Clark et al. investigated the effect of seat cushions on the healing of stage II to stage IV pressure ulcers (Table 55). (106) Thirty-three elderly patients from acute care hospitals were randomized to receive either a four-cell alternating air pressure cushion (Pro-Active 2®, Pegasus Airwave Ltd.) or to a static air-filled cushion (ROHO Quadtro, Raymar Ltd). The Pro-Active Cushion had four inflatable air sacs powered electrically to inflate and deflate in 12-minute cycles. Eight patients (24%) were withdrawn from the study.
Table 55:
Table 55:
A Randomized Controlled Trial Comparing Alternating Pressure Seat Cushion With Static Air Seat Cushion in the Treatment of Pressure Ulcers*
Analysis of the data on the 25 remaining subjects found no statistically significant differences in the occurrence of complete healing or the rate of healing between the study groups (Figures 53--5555).
Figure 53:
Figure 53:
Forest Plot of Ulcers Healed – Alternating Pressure Seat Cushion Versus Static Seat Cushion*
*AP indicates alternating pressure; CI, confidence interval; RR, relative risk.
Figure 55:
Figure 55:
Forest Plot of Rate of Change in Volume of Ulcer – Alternating Pressure Seat Cushion Versus Static Air Seat Cushion*
*AP indicates alternating pressure; CI, confidence interval; SD, standard deviation; WMD, weighted mean difference.
Figure 54:
Figure 54:
Forest Plot of Rate of Change in Area of Ulcer – Alternating Pressure Seat Cushion Versus Static Air Seat Cushion*
*AP indicates alternating pressure; CI, confidence interval; SD, standard deviation; WMD, weighted mean difference.
Comparison 9: Generic Total Contact Seat Versus a Low-Air-Loss Bed and Versus a Low Pressure Mattress Overlay
Rosenthal et al. (92) conducted two separate RCTs of stage III and IV pressure ulcers that compared wound healing on three different support surfaces: a total contact seat, a LAL bed, and a low pressure mattress overlay (Table 56).
Table 56:
Table 56:
Randomized Controlled Trial Comparing a Generic Total Contact Seat With a Low-Air-Loss Bed and a Mattress Overlay*
In the first study, Rosenthal et al. (92) randomized 108 patients to either sitting on a generic total contact seat (maximum 4 hours) or to an LAL suspension bed (TheraPulse) preset for body weight, height, girth, and optimum air-flow, or to a pressure reducing 8.89 cm medium density open-cell polyurethane foam overlay (Geo-Matt). The generic total contact seat redistributed the weight from pressure sensitive bony prominences (ischial tuberosities and the coccyx) onto less pressure sensitive areas (thighs and lateral pelvis). The seat was individually fitted to each subject’s anatomy. The LAL bed consisted of a rack of inflatable fabric pillows attached to a modified bed frame to provide pulsating air support. In the second study, 47 patients that received the same generic total contact seat were compared with 47 residents that received the LAL bed.
Treatment groups did not differ significantly in baseline parameters. In Study 1, contrast estimates showed that PSST scores on the total contact seat were significantly lower (better) than on the LAL bed (P < .001) or on the low pressure foam overlay (P < .001) (Table 56). PSST improvement on the generic seat was also significantly greater than that in the other 2 support surfaces (P < .001 for both contrasts). The generic contact seat was also associated with significantly better PSST compared with the LOL beds in Study 2. In Study 1, 8 subjects that received the total contact seat had a completely healed pressure ulcer after 4 weeks treatment while no complete healing occurred in the other 2 groups (Figure 56). The RR of 17 is only marginally statistically significant and the wide CI (1.02–284.47) precludes any firm conclusion on the impact of generic total contact seat on complete healing (Figures 56 and and57).57). (92)
Figure 56:
Figure 56:
Forest Plot of Ulcers Healed – Total Contact Seat Versus Low-Air-Loss Bed*
*CI indicates confidence interval; RR, relative risk.
Figure 57:
Figure 57:
Forest Plot of Ulcers Healed – Total Contact Seat Versus Low Pressure Foam Mattress Overlay*
*CI indicates confidence interval; LP, low pressure; RR, relative risk.
The patients from the 2 studies were combined for analysis of time to total healing. Eight patients in the overlay group were withdrawn from Study 1 because of worsened condition. Kaplan-Meier analysis showed that the median time to complete healing was significantly shorter in the total contact seat group compared with the LAL bed (3.33 months vs. 4.38 months, log rank = 28.03, P < .001) and with low pressure foam overlay (3.33 months vs. 4.55 months, log rank = 20.64, P < .001). Functional outcomes measured using the 12-point Katz score at 4 weeks were significantly better with the total contact seat (6.6, SD 1.85) compared with the LAL bed (3.1, SD 1.23) and with the low pressure foam overlay (1.9, SD 0.62) (P < .001 for both comparisons). (92)
Comparison 8: Pressure Relieving Devices for the Heel
Pressure ulcer of the heel is one of the most common pressure ulcers for bed-ridden patients. Only 1 RCT examined the influence of special beds and surfaces on the healing of heel ulcers. Russell et al. (96) reported that the Nimbus 3 AP bed with a heel guard that can be powered down resulted in a statistically significant increase in completely healed heel ulcers at 18 months compared with the Pegasus Cairwave mattress that did not have a heel guard [RR 1.67 (95% CI, 1.07–2.59), P = .02].
Other special devices have also been designed to relieve pressure from the heel. These are mainly ankle-foot orthoses such as sheepskin boots and special heel protectors that essentially float the heel, eliminating contact with the support surface. These devices can be used in conjunction with stabilizer wedges; however, the literature searches failed to identify comparative studies that explored the influences of these devices on the healing of heel ulcers. (96)
Table 57:
Table 57:
Alternating Bed With Heel Guard Versus Alternating Bed Without Heel Guard*
Summary of Analysis –Pressure Relieving Support Surfaces and Devices
Table 58:
Table 58:
Summary of Impact of Pressure Relieving Devices on Complete Healing of Pressure Ulcers*
Table 59:
Table 59:
Summary of Impact of Pressure Relieving Devices on Improved Ulcer Healing*
Summary Statements – Pressure-Relieving Support Surfaces
  • There were no comparisons between specialized beds with standard foam mattresses as treatment.
  • An AP mattress with a heel guard that can be powered down was associated with significantly more closure of heel pressure ulcers than AP beds without a heel guard [RR 1.67 (95% CI, 1.07–2.59)].
  • A profiling bed was associated with a significantly higher percentage of healed stage I pressure ulcers than a flat-based bed [RR 5.0 (95% CI, 1.45–17.27)].
  • Patients ambulated to a generic total contact seat for up to 4 hours per day had better healing of stage III or IV ulcers compared with patients confined to a LAL bed or a medium density foam mattress overlay [RR 17 (95% CI, 1.02–284.47)].
  • Support from air-fluidized beds was associated with significantly more improved ulcers than AP beds or mattresses.
  • The studies failed to detect a statistically significant difference in complete closure of pressure ulcers (≥ stage II) between the following treatments:
    • A LAL bed and a convoluted foam mattress
    • A constant low pressure foam and a water mattress
    • An AP mattress replacement and an AP mattress overlay
    • One AP mattress and another AP mattress
An AP seat cushion and a static cushion (although the rate of healing was significantly higher with the AP seat cushion).
Adjunctive Physical Therapies
Hydrotherapy
Only one randomized controlled study on the use of whirlpool as an adjuvant therapy for pressure ulcer was identified (Table 60). The study compared patients from the medical wards of two acute care hospitals that presented with one or more stage III or stage IV ulcers. After sharp debridement of necrotic tissues and confirmation of no symptoms of wound infection, the 24 patients randomized to hydrotherapy received 20 minutes of whirlpool therapy at 96°F to 98°F daily in addition to conventional therapy. The 18 patient control group received only conventional therapy consisting of irrigation with normal saline, wet-to-wet cotton dressing, air mattresses, turning every 2 hours, and Roho seat cushions. (20)
Table 60:
Table 60:
Summary of a Randomized Controlled Trial on Whirlpool Therapy*
The outcome measure was the weekly change in ulcer size represented by the sum of their maximum length and width. The mean weekly change in ulcer size and SD for each group was calculated using the patient-level data. A Forest plot of the mean and SD showed that patients that received adjuvant hydrotherapy had a significantly higher mean rate of reduction in ulcer measurements compared with patients that received only conventional therapy [WMD = –0.28 cm/week, 95% CI (–0.54 to –0.02), P = .04] (Figure 58). The proportion of ulcers with a mean weekly reduction in the size was also higher in the hydrotherapy group compared with the controls (14/24 vs. 5/18), but the difference was not statistically significant (Figure 59). The proportion of ulcers that deteriorated during the study was not significantly different between the two groups (Figure 60).
Figure 58:
Figure 58:
Mean Weekly Change in Ulcer Size – Whirlpool Versus Conventional Therapy*
*CI indicates confidence interval; SD, standard deviation, WMD, weighted mean difference.
Figure 59:
Figure 59:
Proportion of Patients That Experienced a Mean Reduction in Ulcer Measurements per Week – Whirlpool Versus Conventional Therapy*
*CI indicates confidence interval; RR, relative risk.
Figure 60:
Figure 60:
Forest Plot of Ulcers That Deteriorated During the Study – Whirlpool Therapy Versus Conventional Therapy*
*CI indicates confidence interval; RR, relative risk.
There were, however, quality limitations in the above study. The method of randomization was not described and there was no mention of concealment of allocation. No baseline data on the patients or ulcers were provided and, it was thus not possible to determine whether the patient groups were similar at baseline. The minimum follow-up was 2 weeks but the mean and maximum follow-up periods were not reported.
Electrical Stimulation Therapy
Pressure ulcers are characterized by abnormally low electrical potentials, resulting in voltage gradients compared with the surrounding healthy tissue (Bradock et al., 1999) This forms the basis for the use of electrical stimulation to treat pressure ulcers. Early research suggests that electrical stimulation may initiate or accelerate the wound healing process through different mechanisms. Electrical stimulation devices can provide a direct current (monopolar or bipolar) or both direct and alternating currents. Therapeutic electric currents can be delivered into the wound and/or periwound tissue through electrodes applied directly to the patient’s skin (Table 61).
Table 61:
Table 61:
Types of Electric and Electromagnetic Stimulation*
Regulatory Status
At the time of this review, Health Canada has licensed the devices listed in Table 62 for electrotherapy of wounds including pressure ulcers.
Table 62:
Table 62:
Electrotherapy Devices Licensed in Canada for Wound Therapy (as of November 12, 2007)
Systematic Reviews of Electrical Stimulation Therapy
Four previous systematic reviews examined the evidence on the effectiveness of electrical stimulation as an adjunctive therapy for chronic pressure ulcers. These systematic reviews are summarized in Table 63. The current review updated the most recent systematic review (RCN 2005). This review included three of the studies from the RCN review (Gentzkow 1991, Griffin 1991, Wood 1993) and an additional study published since the last review (Adunsky 2005). One study (Ritz 2002) in the RCN review was excluded because it did not involve the use of electrical current. Another study by Adgoke and Badmos (2001) was also excluded as it involved only 3 subjects in each group. The studies are summarized in Table 64.
Table 63:
Table 63:
Previous Systematic Reviews on Electrical Stimulation Therapy on Wound Healing*
Table 64:
Table 64:
Randomized Controlled Trials Comparing Electrical Stimulation With Placebo*
All four studies compared electrotherapy with sham electrotherapy (placebo). The studies were conducted mostly in institutional setting including hospitals and rehabilitation facilities, with the exception of one that included community patients. Three of the studies included mostly elderly patients except the study by Griffin et al., which included male spinal cord patients with average ages of 32.5 and 26 years. Two of the studies included stages II to grade 4 ulcers; one included stages II and III ulcers; and one included only stage III ulcers. Three studies used pulsed electrical stimulation and three used direct current while one used alternating current. Two of the studies reported treatment duration to be 1 hour per day. Duration of the studies (active treatment period) varied from 20 days to 8 weeks.
In the more recent study, Adunsky et al. (112) treated 35 patients with stage III pressure sores with decubitus direct current treatment (DDCT) adjunctive to conservative therapy including debriding and hydrocolloid or collagen dressings for 8 weeks while a control group of 28 patients with stage III pressure ulcers received conservative treatment and sham direct current treatment. Progress of the wounds were assessed and documented during treatment and for a follow-up period of 90 days. Only 38 patients completed the study. The group treated with direct current exhibited a higher rate of absolute ulcer reduction during the first 45 days (–0.44 vs. –0.14). There were, however, no statistically significant differences between the groups in complete wound closure (DDCT 25.7% vs. 35.7% for placebo, P = .28) or in the mean time to complete closure [63.4 (SD 15.1) days for DDCT group vs. 89.7 (SD 9.2) days for the placebo group, P = .016]. Per protocol analysis of the 38 patients that completed the study showed that complete healing was better in the DDCT group (5 vs. 1) and the time needed for wound closure at the end of the follow-up period was 52% longer for the placebo group compared with the DDCT group (102 vs. 67 days, P = .0329). (112) The results of the studies are summarized in Table 65.
Table 65:
Table 65:
Outcomes of Randomized Controlled Trial Comparing Electrotherapy With Sham Therapy*
Gentzkow et al. and Griffin et al. (110) reported significantly greater reduction in the mean area of ulcers treated with electrotherapy compared with sham therapy. Wood et al. (111) reported that significantly more ulcers treated with electrotherapy achieved a greater than 80% reduction in the area of the ulcer compared with sham therapy.
Three studies (110-112) provided information on complete ulcer closure. These were included in a pooled analysis. All three showed a higher proportion of complete healing in the electrotherapy group compared with the sham therapy group, but the difference in complete healing was statistically significant only in one of the studies (Wood et al., 1993). The Forest plot of complete healing of ulcers during treatment showed that electrotherapy was more than 4 times as effective as sham treatment in healing ulcers [RR 4.48, (95% CI, 1.91–10.51), P = .0006]; however, the there was significant heterogeneity among the studies (I2 = 70.1%, P = .04) (Figure 61). When the Forest plot was repeated using the random effects model, the difference in complete healing between the electrical stimulation group and the placebo group was not statistically significant and the test for heterogeneity was still significant (Figure 62).
Figure 61:
Figure 61:
Forest Plot of Ulcers Healed – Electrotherapy Versus Sham (ITT data) – Fixed Effects Model*
*CI indicates confidence interval; RR, relative risk.
Figure 62:
Figure 62:
Forest Plot of Pressure Ulcer Healed – Electrotherapy Versus Sham Electrotherapy (Random Effect Model)*
*CI indicates confidence interval; RR, relative risk.
Summary
There is evidence to suggest that electrical stimulation is associated with greater relative reduction in area of pressure ulcers and may increase the healing of pressure ulcers compared with sham therapy. However, because of the small sample size of the studies and the significant heterogeneity, the results need to be interpreted with caution.
Electromagnetic Stimulation
Electromagnetic therapy of pressure ulcers involves the use of pulsed electromagnetic fields in the radiofrequency band without thermal effects. It is different from electrical stimulation therapy in that it does not involve the use of current, leads, or electrodes. The therapy is believed to stimulate blood flow and promote cell proliferation for wound healing. Contraindications for electromagnetic therapy of pressure ulcers include infection, necrosis, pacemakers not identified as RF-compatible, immature bone development, pregnancy, metal implants at the ulcer site, and documented or suspected malignancy at the ulcer site (CIGNA Health Care coverage position November 15, 2006).
At the time of this review, the ROMA 3 Electrotherapeutic Signal Generator (T.H.E. Medicals) was the only electromagnetic device licensed for wound therapy in Canada. No published studies on this device were found in the literature search. Three RCTs were found using electrotherapy devices licensed in other countries.
Of note, the FDA has approved PROVANT, a short wave diathermy device that applies electromagnetic energy to the body in the radiofrequency bands of 13 megahertz to 27.12 megahertz. (113)
Three previous systematic reviews on electromagnetic therapy for treating pressure ulcers were found: Cullum et al., 2001, (89) Royal College of Nursing and National Institute for Clinical Excellence 2006, (46) and Olyaee Manesh et al., 2006 (114)). These reviews and their conclusions are summarized in Table 66. All three reviews included the same two RCTs (Comorosan 1993 and Salsberg 1995). These studies were thoroughly reviewed and analyzed including quality assessment. The characteristics of these studies are summarized in Table 67 and the results are summarized in Table 68.
Table 66:
Table 66:
Summary of Systematic Reviews on Electromagnetic Therapy as a Treatment of Pressure Ulcers*
Table 67:
Table 67:
Characteristics of the Randomized Controlled Trials on Electromagnetic Therapy of Pressure Ulcers
Table 68:
Table 68:
Results of Randomized Controlled Trials on Electromagnetic Therapy of Pressure Ulcers*
Impact on Complete Healing
Salsberg et al. (116) only reported on complete healing for grade 3 ulcers while the other 2 studies reported on complete healing for both grade 2 and grade 3 ulcers. A Forest plot that compared electromagnetic therapy with sham therapy with respect to ulcers healed (grade 2 and 3) showed significant heterogeneity (I2 = 75.3%, P = .02) (Figure 63).
Figure 63:
Figure 63:
Comparison of Complete Healing – Electromagnetic Therapy Versus Sham Therapy*
*CI indicates confidence interval; RR, relative risk.
Impact on Healing Process
The above analyses suggest that electromagnetic stimulation does not appear to have a beneficial effect on complete healing of pressure ulcers.
Of note, Comorosan et al. (115) reported that in the electromagnetic therapy group, 85% of the patients achieved complete healing and the remaining 15% experienced very good healing (75% to 95% healed), whereas the placebo group and the conventional treatment group exhibited either poor healing or no improvement. Ritz et al. (117) reported that the radiofrequency treatment group had a significantly greater mean reduction in ulcer surface area (87% vs. 56%, P = .05) and that the rate of wound closure was greater than in the sham cohort. It was unclear whether this difference was statistically significant.
Low-Level Laser Therapy
Lasers have been used for surgery, relief of pain, treatment of soft-tissue injuries, and control of inflammation. It was believed that lasers might favour wound healing because it has been shown to promote fibroblast proliferation, collagen production, and epithelialization. Moreover, lasers enhance succinic dehydrogenase activity and alter prostaglandin levels at the cellular level.
Low-level laser (LLL) therapy or cold lasers use radiation intensities so low that it is thought that any biological effects that occur are due to the direct effect of radiation rather than the result of heating. Energies delivered are typically about 10 joules per cm2, using lasers operating at powers of 50 mW or less. Low-level lasers include the gallium aluminum (GaAl), gallium-arsenide (GaAs), gallium-aluminum-arsenide (GaAlAs), and helium-neon (He-Ne) lasers. Lasers are primarily defined by wavelength, energy, energy density, and power density. Wavelengths of lasers from helium neon are in the visible light range, and those from GaAlAs and GaAs are in the infrared region of the light spectrum. (118) Several devices have been licensed by Health Canada to provide laser therapy for wound healing. These are summarized in Appendix 7.
Previous Systematic Reviews
No systematic reviews on the use of laser therapy to promote healing of pressure ulcers alone were found. The literature search identified three previous systematic reviews (118-120) on the use of LLL to treat wounds (Table 69) (all three reviews included studies on chronic wounds). Studies on pressure ulcers only accounted for 25% to 33% of all the studies in the reviews. None of the above systematic reviews found any evidence that the addition of LLL therapy would improve the healing of chronic wounds including pressure ulcers. The literature search for the present review identified an additional study on LLL treatment of pressure ulcers. (121) The four studies specifically evaluating the application of LLL therapy for the treatment of pressure ulcers are summarized in Table 70 and Appendix 4.
Table 69:
Table 69:
Summary of Previous Systematic Reviews on Laser Therapy of Pressure Ulcer*
Table 70:
Table 70:
Characteristics of the Randomized Controlled Studies on Laser Therapy for Treatment of Pressure Ulcer*
All 5 studies reporting on the treatment of laster therapy (4 for LLL, one for laser therapy) reported in Table 70 are RCTs with sample sizes ranging from 16 to 86 ulcers. Three of the studies included elderly patients (mean age > 80 years) in hospitals or nursing homes and two included patients with spinal cord injuries. The 2000 study by Lucas et al. (122) was a preliminary exploration prior to the larger study published by the same group in 2003. Three of the studies compared LLL to conventional therapy. Taly et al. (121) compared LLL to sham therapy while Nussbaum et al. compared LLL to a combination of ultrasound and ultraviolet C radiation. The quality of the studies ranged from high to low. Two of the studies reported on the method of randomization; concealment of allocation was reported by one study and all but one study had independent assessors of outcomes blinded to treatment allocation. Results of the studies are summarized in Table 71. Low-level laser therapy appears to be safe; no adverse events were reported in any of the studies.
Table 71:
Table 71:
Outcomes of Randomized Controlled Trials on the Use of Low-Level Laser Therapy to Treat Pressure Ulcers*
Impact on Complete Healing
Three of studies (121;122;125) reported data on complete healing and complete healing was estimated from a graph in a third study. (123) A Forest plot comparing complete healing in the laser therapy group with that in the conventional therapy group showed moderate heterogeneity (I2 = 50.4) and no statistical significant difference between groups in the proportion of ulcers that completely healed [RR 1.26, (95% CI, 0.82–1.95), P = .29] (Figure 64). There was also no statistically significant difference in complete healing between LLL therapy and sham laser therapy reported in 1 of the 4 studies (Figure 65). A Forest plot of studies that compared LLL therapy with either conventional therapy or sham therapy also failed to show any statistically significant benefit from adjuvant laser therapy on complete healing (Figure 66).
Figure 64:
Figure 64:
Forest Plot of Ulcers Healed – Low-Level Laser Therapy Versus Conventional Therapy*
*CI indicates confidence interval; LL, low-level; RR, relative risk.
Figure 65:
Figure 65:
Forest Plot of Ulcers Healed – Low-Level Laser Therapy Versus Sham Laser Therapy*
*CI indicates confidence interval; LL, low-level; RR, relative risk.
Figure 66:
Figure 66:
Forest Plot of Ulcers Healed – Low-Level Laser Therapy Versus Sham Therapy or Standard Care*
*CI indicates confidence interval; LL, low-level; RR, relative risk.
Impact on Ulcer Size
The studies reported conflicting results on the impact of LLL therapy on the size of pressure ulcers. Nussbaum et al. (123) and Lucas et al. (122;125) reported no statistically significant difference in the mean absolute or relative reduction in ulcer area between the laser treated group and the group treated with conventional therapy alone; however, Shubert et al. (124) reported significantly greater mean weekly reduction in ulcer size and a greater relative reduction in ulcer size at week 4 for patients treated with LLL. Taly et al. reported better PSST scores for the stage III and IV ulcers that received LLL treatment compared with similar ulcers that received sham therapy. (121) Only Shubert et al. reported a significantly shorter time to achieve healing in patients that received LLL treatment. (124)
Ultrasound Therapy
One 2006 Cochrane systematic review on ultrasound therapy for pressure ulcers was found. (126) This review included all randomized controlled studies that were published up to May 2006 and compared the use of ultrasound for pressure ulcer treatment with sham ultrasound, no ultrasound, or alternative treatments. There was no restriction to the age of patients, care setting, or severity of the pressure ulcer. Primary outcomes included any objective measures of healing and secondary outcomes included costs, quality of life, pain, and acceptability. Three RCTs met the inclusion criteria and were included in the systematic review and are summarized in Table 72 and Appendix 4. (123;127),(128). No new studies were found in the current review.
Table 72:
Table 72:
Randomized Control Trials on Ultrasound Therapy of Pressure Ulcers
Two of the studies(127;128) compared therapeutic ultrasound with sham ultrasound, while the third study compared combined ultrasound/ultraviolet C (US/UVC) therapy with laser therapy and conventional therapy. The latter study has been described in the previous section. All three studies used ultrasound with frequency of approximately 3 MHz for 3 to 5 treatments per week. There was some heterogeneity in the special and temporal averaged (SATA) intensity, effective radiation area, and treatment duration. The duration of the study ranged from 60 days to 12 weeks. One of the studies included ulcers equivalent to NPUAP stage II while the study by ter Riet et al., (128) included stages III and IV. The third study by McDiarmid et al., (127) did not clearly state the stage of the ulcers included in the study. Results of the RCTs are summarized in Table 73.
Table 73:
Table 73:
Outcomes of Randomized Controlled Trials on Ultrasound Therapy of Pressure Ulcers*
Ultrasound Therapy Versus Sham Ultrasound
A Forest plot of the 2 studies that compared ultrasound therapy with sham ultrasound therapy found no significant between-group differences in the proportion of ulcers that completely healed [RR 0.97, 95% CI (0.65–1.45), P = .89]. The test for heterogeneity was negative (I2 = 0%, P = .61) (Figure 67).
Figure 67:
Figure 67:
Forest Plot of Ulcers Healed – Ultrasound Therapy Versus Sham Therapy*
*CI indicates confidence interval; RR, relative risk.
Ter Riet et al. (128) reported no statistically significant difference in the mean absolute or relative reduction in surface area or healing time of the ulcers between the ultrasound and the sham groups. McDiarmid et al. (127) reported similar relative reduction in wound size at 4 weeks for clean (uninfected) ulcers, but a significantly greater reduction in the ultrasound group compared with the sham group for infected ulcers. Ter Riet et al. conducted a subgroup analysis to compare the effect of ultrasound on infected and on uninfected ulcers, but failed to find any statistically significant difference in ulcer healing or healing time. It should be noted that the study by ter Riet et al. included stage III and stage IV ulcers in addition to stage II ulcers, whereas the study by McDiarmid included only stage II ulcers. This may partly account for the difference in findings between these studies.
Combined Ultrasound and Ultraviolet C Therapy Versus Standard Care
Nussbaum et al. (123) compared combined US/UVC with LLL therapy and with standard wound care. The number of subjects in each group was (9 in US/UVC, 7 in sham, and 6 in standard care). After 4 patients withdrew from the study, only 6 patients were left in each of the 3 arms. After 12 weeks of treatment, all 6 pressure ulcers had completely healed in the US/UVC group while 4 healed in the laser group and 5 healed in the standard care group. Forest plots of these results showed that US/UVC C therapy did not significantly improve complete healing compared with LLL therapy [RR 1.50 (95% CI, 0.865–2.64), P = .16] or with standard care [RR 1.2 (95% CI, 0.84–1.72), P = .32] (Figures 68 and and6969).
Figure 68:
Figure 68:
Forest Plot of Complete Healing at 12 Weeks – Ultrasound/Ultraviolet C Therapy Versus Low-Level Laser Therapy*
*CI indicates confidence interval; LLL, low-level laser; RR, relative risk; US/UVC, ultrasound/ultraviolet C.
Figure 69:
Figure 69:
Forest Plot of Complete Healing at 12 Weeks – Ultrasound and Ultraviolet C Therapy Versus Standard Care*
*CI indicates confidence interval; RR, relative risk; US/UVC, ultrasound/ultraviolet C.
Nussbaum et al. (123) reported that combined US/UVC therapy resulted in a statistically significant higher relative reduction in ulcer area compared with laser therapy (53.5% vs. 23.7%, P = .032), but the difference in relative ulcer reduction between US/UVC and standard care (53.5% vs. 32.4%) was not statistically significant. Nussbaum et al. also reported that ulcers treated with US/UVC healed faster than those treated with standard care (mean healing time 6 weeks vs. 13 weeks) or with LLL therapy (6 weeks vs. 20 weeks); however, it is unclear whether this was statistically significant as no P value was provided.
Summary
This review confirmed the findings of Baba-Akbari Sari et al. (126) that there is presently no evidence of a benefit of using ultrasound therapy in the treatment of pressure ulcers and that the possibility of a beneficial or harmful effect cannot be ruled out due to the very small number of trials. Because of the small number of subjects in each trial, a type 2 error cannot be ruled out. The quality of the studies also needs to be considered. Although the study by ter Riet et al. (128) was very high quality, the other two studies had methodological limitations including an unclear method of randomization, concealment of allocation, and no intention-to-treat analysis. McDiarmid’s finding suggests that ultrasound therapy may have a beneficial effect in the healing of infected wounds. This finding still needs to be confirmed, since ter Riet et al. were not able to reproduce this effect.
Ultraviolet Light Therapy
Ultraviolet light contains type A, B, and C wavelengths. Ultraviolet light has been investigated as a treatment for wounds. It is believed that ultraviolet light might increase epithelial cell turnover, remove slough, stimulate granulation and epithermal growth, and destroy bacteria. Only two studies have examined the impact of ultraviolet light on the healing of pressure ulcers (Table 74).
Table 74:
Table 74:
Randomized Controlled Trials on Ultraviolet Light as a Treatment for Pressure Ulcer*
Nussbaum e al. (123) reported that adding ultraviolet C therapy did not improve complete healing but resulted in significantly greater reduction in area of the ulcers compared with LLL therapy and shorter healing time compared with LLL therapy and standard care (see previous section).
In a small RCT involving 16 patients, Wills et al. (129) compared treatment of superficial pressure ulcers (< 5 mm deep) treated twice weekly with ultraviolet light (predominantly A and B) to similar pressure ulcers treated with sham ultraviolet light (a mica cap covers the quartz window in the lamp). Virtually all pressure ulcers in the study were infected. The only result reported was mean time to heal which was significantly shorter in the ultraviolet group than the control group (6.25 weeks vs. 8.38 weeks, P < .02). This difference persisted even when each patient’s age and the initial size of the pressure ulcer were taken into account by covariance analysis. Yet, despite these promising results, there are concerns regarding ultraviolet radiation’s mutagenic effect in causing skin cancer.
Negative Pressure Wound Therapy
Negative pressure wound therapy (NPWT), commonly known as vacuum-assisted wound therapy, uses negative pressure to create suction that removes exudate, while keeping the wound environment moist. This technique involves placing a large piece of foam over the wound with a drain tube. A large piece of transparent tape is then placed over the whole area including the surrounding healthy tissue. The drain tube is connected to a vacuum source to create negative pressure and fluid drawn from the wound is drained into a disposable canister. The system can be programmed to provide varying degrees of pressure either continuously or intermittently. (130)
A systematic review performed by MAS in 2006 examined the effectiveness of NPWT for healing wounds including pressure ulcers, diabetic ulcers, sternal wounds, and skin grafts. (130) The review concluded that, based on the evidence available at the time, the clinical effectiveness of NPWT for wound healing is unclear. As a result, OHTAC recommended that a field evaluation be performed to clarify the its effectiveness in this role. This field evaluation, coordinated and overseen by the Program for Assessment of Technology in Health (PATH) at McMaster University, is presently in progress. Of the six 6 RCTs included in the 2006 MAS review, two studies addressed pressure ulcers alone and one addressed nonhealing wounds that were predominantly pressure ulcers (Table 75). No additional randomized studies on the use of NPWT to treat pressure ulcers were found.
Table 75:
Table 75:
Randomized Studies – Negative Pressure Therapy in the Treatment of Pressure Ulcers*
Ford et al. (2003) compared NPWT with HealthPoint gel in the treatment of stage III and IV ulcers. Forty-one patients were randomized to receive either vacuum-assisted closure (VAC) or a HealthPoint gel. Wounds in the control group that showed substantial exudates were treated with Indosorb or Indoflex gel (hydrophilic beads containing cadexomer iodine) while clean and granulating ulcers were treated with Panafil gel (a papin-urea-chlorophyllin-copper ointment). At the end of the 6-week trail (31 patients completed), no statistically significant differences were found between the study groups in the proportion of ulcers that healed completely (3/20 vs. 2/15) (Figure 70), mean percent reduction in ulcer volume (51.8% vs. 42.1%, P = .46), or the mean change in the number of polymorphonuclear neutrophils, lymphocytes, and capillaries per high power field.
Figure 70:
Figure 70:
Ulcers Healed – Negative Pressure Therapy Versus HealthPoint Gels*
*CI indicates confidence interval; RR, relative risk.
Wanner et al. (2004) compared 11 pressure ulcers (≥ grade 2) treated with NPWT with 11 similar grade ulcers treated with wet-to-dry/wet-to-wet gauze dressing soaked in Ringer’s solution. At the end of the study, no significant difference was found between the study groups in the mean time needed to achieve 50% reduction of the initial wound volume. No data on complete healing of wounds was reported.
Joseph et al. (2000) compared nonhealing chronic wounds of at least 4 weeks duration treated with NPWT with those treated with wet-to-moist gauze dressing. Of the 36 wounds in the study, 28 (79%) were pressure ulcers. After 6 weeks of treatment, wounds treated with NPWT were found to have a significantly greater reduction in the depth, width, and mean volume compared with the wounds treated with wet-to-moist dressing; however, no data on complete healing of wounds were reported. Histologically, granulation tissue formation was observed in 64% of wounds treated with NPWT, whereas 81% of the wounds treated with wet-to-moist dressing displayed inflammation and fibrosis.
The above studies showed conflicting results in the influence of NPWT in reducing the volume of wounds. None used complete healing as the primary outcome even though one study reported that NPWT did not result in a significantly higher proportion of complete wound closures compared with traditional gauze dressing. No study compared NPWT with the modern dressings presently used in Ontario. Moreover, all three studies had small sample size and methodological flaws including no a priori power calculation, no blinded assessment of outcomes, and no intention-to-treat analysis, despite patient withdrawal. Hence, the role of NPWT in the healing of chronic pressure ulcers is unclear at this time.
Summary Analysis – Adjunctive Physical Therapies
Table 76:
Table 76:
Impact of Adjunctive Physical Therapies on Complete Healing*
Table 77:
Table 77:
Impact of Adjunctive Physical Therapies on Reduction in Ulcer Size
Summary Statements – Adjunctive Physical Therapy
  • There is evidence that electrical stimulation may result in a significantly greater reduction in the surface area and more complete healing of stages II to IV ulcers compared with sham therapy. These results need to be confirmed because of small sample sizes and presence of significant heterogeneity.
  • The efficacy of other adjunctive physical therapies in improving complete closure of pressure ulcers has not been established.
Nutritional Therapy
Systematic Reviews
The search yielded three systematic reviews on the use of nutritional therapy in treating pressure ulcers. These are briefly summarized in Table 78.
Table 78:
Table 78:
Systematic Reviews of Nutritional Therapy in Treating Pressure Ulcers*
Two of the systematic reviews are independent reviews addressing only nutritional therapy (134;135), while the third is a part of a comprehensive review of all treatments (RCN 2005). Two systematic reviews only included studies on treatment (Langer 2003, RCN 2005) and the third addressed both prevention and treatment of pressure ulcers. (Stratton 2005) Two reviews included only RCTs (Langer 2003 and RCN 2005), but one also included controlled trials (Stratton 2005). Langer et al. (2003) and RCN (2005) included studies using any form of nutritional supplement whereas Stratton 2005 focused on multinutrient oral supplements and enteral tube feedings.
The current review updates the two 2005 systematic reviews. Two new published RCTs on nutritional therapy were found (Lee 2006 and Desneves 2005). These studies, and those included in previous systematic reviews, are discussed below.
MAS Review of Studies in Nutritional Therapy
Protein Supplements
Two RCTs examined the effect of protein supplements on the healing of ulcer (Table 79).
Table 79:
Table 79:
Comparison of Protein Supplements and Placebo*
In an RCT, Lee et al. (136) explored the effect of protein supplement on the healing of stage II, III, and IV pressure ulcers in long-term care residents. The trial compared 56 residents of long-term care facilities that received standard care plus a concentrated fortified collagen protein hydrolysate supplement for 8 weeks with 33 counterparts who received standard care and a placebo. Seventy-one of the subjects completed the study: 44 in the treatment group with 75 pressure ulcers and 27 in the placebo group with 33 pressure ulcers. At 8 weeks, the protein hydrolysate group showed twice the rate of pressure ulcer healing compared with the placebo group (mean improvement in PUSH score 5.56 for treatment vs. 2.85 for placebo). There were no significant differences among the groups in the rate of adverse events.
Zinc Supplementation
Zinc is a trace mineral that is an integral part of many body tissues and enzymes. It plays an important part in the synthesis of deoxyribonucleic acid and ribonucleic acid that foster tissue growth and healing, as well as collagen synthesis. Zinc deficiency is associated with hair loss, diarrhoea, poor appetite, decrease in sense of taste and smell, and lesions in the skin and eye. A study had shown that up to 88% of eating-dependent nursing home residents had dietary zinc intake below 50% of the recommended daily allowance. Hence dietary supplementation of zinc had been investigated as a treatment for pressure ulcers. (Posthauer 2005, Advances in Skin and Wound Care)
The previous systematic reviews included two studies relating to zinc supplementation in the healing of pressure ulcers (137;138) (Table 80). There have been no new studies since the 2005 systematic review and no new studies were found in the current review. The following is based on the 2005 RCN review.
Table 80:
Table 80:
Randomized Controlled Trial Comparing Zinc Supplement With Placebo*
In a randomized, double-blind crossover study, Norris et al. randomized 14 patients with pressure ulcers to receive either 200 mg zinc sulphate or placebo 3 times daily placebo for 24 weeks. Volume of the ulcers was measured every 4 weeks and after 12 weeks the groups switched therapy. Only 3 patients completed the study. The mean net change in the volume of pressure ulcers was 10 mL (SD 9 mL) in the zinc sulphate treated group compared with a net change of 6.0 mL (SD 17.5 mL). The difference between the groups was not statistically significant (WMD 4.1 mL; 95% CI, –8.10 to 16.30, P = .5)
Brewer et al. (1967) reported no significant difference in the rate of pressure ulcer healing in spinal cord injury patients treated with 220 mg of zinc sulphate 3 times daily for 2 to 3 months (1/6 with healed pressure ulcer) compared with patients receiving a placebo (2/7 patients healed).
A pooled analysis of the studies was performed. The Forest plot of ulcers healed showed no significant difference in the proportion of ulcers healed between patients who received zinc supplement and patients who received a placebo [RR 0.97, (95% CI, 0.22–4.29), P = .96] (Figure 71). The test for heterogeneity was not significant. There is a possibility of type 2 error since both studies were very small.
Figure 71:
Figure 71:
Forest Plot of Ulcers Healed – Zinc Supplement Versus Placebo*
*CI indicates confidence interval; RR, relative risk.
Houston et al. compared the adverse effects of 26 older institutionalized patients that received 440 mg zinc sulphate daily for the treatment of pressure ulcers with 44 patients with pressure ulcers that received similar care without zinc sulphate supplementation. After 30 days of treatment, the beneficial effects of zinc sulphate on healing were not obvious. The only significant difference in healing between the groups over the 30 days was greater improvement in ulcer volume in patients with stage III or IV ulcer (P < .05), but not in stage II. However, zinc sulphate supplementation was associated with a higher incidence of adverse events. The odds of an infection requiring antibiotic therapy were 7.8 times greater in patients receiving zinc sulphate (P < .009). In addition, subjects with zinc sulphate were 12.5 times more likely to experience nausea/vomiting than were comparison subjects receiving similar care without zinc sulphate (P < .02). Adverse effects could not be explained by the presence of diabetes mellitus or differences in energy intake. (Houston, Haggard et al., 2001, Journal of American Geriatric Society 49 (8): 1130)
Ascorbic Acid Supplementation
Ascorbic acid is the enolic form of vitamin C. In addition to its antioxidative effects, vitamin C also plays an important role in tissue repair and regeneration within the body. It acts as a cofactor for enzymes involved in the synthesis of connective tissues, in particular collagen, an important process in wound healing. Vitamin C deficiency has been associated with risk of pressure ulcer (Gray 2003 Journal of wound ostomy continence nursing). Elderly subjects admitted for femoral bone fracture that developed pressure ulcers were found to have leukocyte vitamin C levels about 50% lower than those in similar patients that remained ulcer free (Selvaag 2002).
The previous systematic reviews included two studies on vitamin C supplementation on the healing of pressure ulcers, which yielded conflicting results as summarized in Table 81 (the current review did not identify any new studies on this treatment). Tayor et al. (139) compared 10 surgical patients with an existing pressure ulcer who received 500 mg of ascorbic acid twice daily with 10 patients who received a placebo twice daily. Both groups received similar wound care. After 1 month, 6 of the patients in the ascorbic acid group had complete ulcer closure compared with 3 patients in the placebo group. This difference was not statistically significant; however, patients in the ascorbic acid group showed significantly greater reduction in the mean ulcer area compared with the placebo group (84% vs. 42.7%, P < .005).
Table 81:
Table 81:
Randomized Controlled Trials on the Effect of Vitamin C Supplementation on the Healing of Pressure Ulcers*
In a more recent RCT, ter Riet et al. (140) compared 42 nursing home patients with a pressure ulcer (grade 2 or worse) that received 500 mg ascorbic acid twice daily with 45 residents that received 10 mg ascorbic acid twice daily. Patients in each group were also randomized to receive either ultrasound therapy or sham ultrasound therapy. After 12 weeks, there were no significant differences in the rate of absolute or relative reduction in surface area or volume of the ulcers between the groups. Ter Riet et al. (140) pointed out that there were differences between the studies such as age, setting, mean size of ulcers at baseline, and the amount of ascorbic acid received by the controls (none vs. 20 mg daily). For this reason, it is not appropriate to pool the two studies.
Multinutrient Supplement
The use of multinutrient (mixed nutrient) liquid nutritional supplements is a common practice to provide additional protein, energy, vitamins, and minerals to people requiring additional nutrition support. The supplement can be taken orally or administered in the form of tube feedings. The 2005 systematic reviews (Stratton and RCN) together included three RCTs that examined the effect of multinutrient nutritional supplements on the healing of pressure ulcers. (Ek 1991, (141) Chernoff 1999 (142), Benati 2001 (143)) One new study was found in the course of the MAS literature search (144); the four studies are summarized in Table 82.
Table 82:
Table 82:
Randomized Controlled Trials – Added Multinutrient Enteral Supplement Versus Standard Diet*
With the exception of the study by Ek et al. (141) (501 patients followed for 26 weeks), the studies were generally small (N ranged from 12–16) with short durations (2–8 weeks). Most of the study subjects were elderly and institutionalized. Pooling of the results was not possible since these studies used different outcome measures (percentage of ulcers healed, reduction in surface area, change in PSST score, and change in PUSH scores).
Ek et al. (141) studied the effect of a high protein, high calorie, vitamin and mineral-enriched liquid supplement on the development and healing of pressure ulcers. At the end of 26 weeks, 28 of the 67 (41.8%) pressure ulcers in the supplement group had healed compared with 25 of 83 (30.3%) pressure ulcers in the group that only received a standard diet. Although the nutritional supplement group had a higher incidence of healed ulcers compared with the control group (RR 1.39), this difference did not reach statistical significance (95% CI, 0.90–2.14, P = .14) (Figure 72).
Figure 72:
Figure 72:
Forest Plot of Ulcers Healed – Multinutrient Supplement Versus Standard Diet*
*CI indicates confidence interval; RR, relative risk.
Chernoff et al. (142) reported in an RCT that 4 out of 6 institutionalized tube-fed patients that received a very high protein (25% of energy) enteral tube feeding had healed ulcers whereas none of the patients receiving a standard high protein (16% of energy) formula had healing of their pressure ulcers. The group receiving a very high protein formula also had a 73% reduction in the surface area of the pressure ulcers compared with a 42% reduction in the control group. The differences in the rate of healing and surface reduction of the pressure ulcers did not reach statistical significance.
Benati et al. (143) reported on the results of 16 hospitalized patients with severe cognitive impairment that were randomized into 3 arms. The study compared the effect of a high protein, high calorie supplement enriched with arginine, zinc, and antioxidants (vitamins A, C, and E) with a group receiving a similar supplement without the enrichment and a control group receiving a standard hospital diet. Benati et al. reported that patients treated with the supplement enriched with arginine, zinc, and antioxidants seemed to have the lowest pressure sore status tool score (best healing) and more rapid improvement. No numerical data was provided, however, and the statistical significance cannot be assessed.
Desneves et al. (144) conducted a similar study to explore the effect of a high protein, high energy supplement enriched with arginine, zinc, and vitamin C. This treatment was compared with treatment with the same high protein, high energy supplement without enrichment and to the standard hospital diet. At the end of 3 weeks, patients that received supplementary arginine, zinc, and vitamin C had significantly better PUSH scores (P < .05) and had approximately 2.5-fold greater improvement in PUSH score compared with the other 2 groups, even though there were no significant differences in the patients’ intake of protein and energy among the 3 groups.
Figure 73 shows that the decrease in PUSH scores (improvement in pressure ulcer healing) was –6.8 for the arginine-zinc-vitamin C enrichment group compared with –2.0 for the standard supplement group and –1.7 for the hospital diet group. However, there is insufficient data to determine whether the differences in improvements among the groups are statistically significant.
Figure 73:
Figure 73:
Forest Plot of Weighted Mean Difference of Change in PUSH Scores Before and After Treatment for Each of the Study Arms*
*CI indicates confidence interval; PUSH, Pressure Ulcer Scale for Healing, SD, standard deviation; WMD, weighted mean difference.
Summary of Analysis – Nutrition Therapy
Table 83:
Table 83:
Impact of Nutritional Support on Complete Healing and Area Reduction of Pressure Ulcers*
Summary Statements – Nutrition Therapy
  • Supplementation with 15 grams of hydrolyzed protein 3 times daily did not affect complete healing but resulted in a 2-fold improvement in PUSH score compared with a placebo.
  • Supplementation with 200 mg of zinc 3 times daily did not have any significant impact on the healing of pressure ulcers compared with a placebo.
  • Supplementation of 500 mg ascorbic acid twice daily was associated with a significantly greater decrease in the size of the ulcer compared with a placebo but did not have any significant impact on healing when compared with supplementation of 10 mg ascorbic acid 3 times daily.
  • A very high protein tube feeding (25% of energy as protein) resulted in a greater reduction in ulcer area in institutionalized tube-fed patients compared with a high protein tube feeding (16% of energy as protein).
  • Multinutrient supplements that contained zinc, arginine, and vitamin C were associated with a greater reduction in the area of the ulcers compared with standard hospital diet or to a standard supplement without zinc, arginine, or vitamin C.
It should be noted, however, that firm conclusions cannot be drawn because of methodological flaws and the small sample size.
Multidisciplinary Wound Care Teams
In addition to treatment modalities used to aid healing of pressure ulcers, much attention is being focused on the approach to delivering wound care to people with pressure ulcers in the different health care settings. One of the most common forms of structured wound care delivery is the establishment of a multidisciplinary wound care team that includes wound care specialists, nurses, pharmacists, dietitians, physiotherapists, and discharge planners.
Although there are many reports describing the organization and operation of multidisciplinary wound care teams, most teams reported their impact on the incidence of new pressure ulcers. Only 2 studies reported on the impact of multidisciplinary teams on the healing of pressure ulcers. These 2 studies are summarized in Table 84.
Table 84:
Table 84:
Studies Comparing Multidisciplinary Pressure Ulcer Care With Standard Care*
In a presentation to an international conference in 1993, Alvarez et al. (145) reported on a randomized study involving 66 patients in an urban acute care setting. Patients were randomized into 2 treatment groups. One group was managed by a trained team consisting of 4 full-time registered nurses, a full-time physician, a registered dietitian, a physiotherapist, and a discharge planner. The control group was managed as per the physician according to the standards of the facility. Patients were followed until the pressure ulcer healed, up to a maximum of 8 weeks. At the end of the 8-week period, patients managed by the multidisciplinary team had significantly more pressure ulcers healed (58% vs. 14%, P value not reported) and improved ulcers (45% vs. 28%, P value not reported), shorter length of stay (32.6 days vs. 59.5 days, P < .005), and lower average cost ($29,902 vs. $40, 340 US) compared with patients in the control group. However, since only an abstract of this study is available, the exact number of patients allocated to each group was not available and the RR of ulcer healing could not be estimated.
Because of the paucity of studies on this subject, a pseudo-randomized trial is also included in this review. Vu et al. (10) reported on a pseudo-randomized pragmatic cluster trial in which 342 uncomplicated leg and pressure ulcers in 176 nursing home residents were allocated to 2 treatment groups based on by nursing home and region. Approximately 75% of the wounds were pressure ulcers. Wounds in the experimental group were managed by a team consisting of a pharmacist and a nurse trained in wound management using a standard treatment protocol based on an assessment of the wound. The team held weekly discussion of wounds and also telephone discussion regarding treatment. Ulcers in the control group received usual wound care from nurses with no wound care training according to the Commonwealth manual. Residents in the intervention arm were more likely to be underweight or overweight (P = .000) and less likely to have a history of leg or pressure ulcers (P = .011) compared with control residents. Wounds in the intervention arm were more likely to be severe with greater mean width and higher proportion with moderate or profuse exudates. Patients were followed until their wound(s) healed to a maximum of 6 months. At the end of the study period, 59.7% (80/134) of the pressure ulcers in the team-managed group had completely healed compared with 49% (58/117) in the control group. This result favours team management, but the difference did not reach statistical significance [RR 1.20 (95% CI, 0.96–1.52), P = .11] There were no statistically significant differences in the mean time to achieve complete healing between the 2 groups (82 days vs. 101 days, P = .095). When all wounds were considered, patients managed by the team had greater pain relief compared with the controlled arm (38.6% vs. 24.4%, P = .017). Mean treatment cost per patient including training was lower for the team-managed group compared with the control group ($575.6 vs. $1,005, Australian currency). (10)
Both studies reported improved healing of pressure ulcers in patients managed by a multidisciplinary team compared with the standard approach – management directed by a physician; however, the improvement in healing was significant only in the RCT. It should be noted that in the pragmatic study by Vu et al., (10) the team only consisted of a nurse and a pharmacist, whereas in the RCT by Alvarez et al., (145) the team included more disciplines. The follow-up period was also much longer in the study by Vu et. al. (10) (6 months vs. 8 weeks) compared with the study by Alvarez et al. (145)
Summary of Analysis – Multidisciplinary Wound Care Teams
The only RCT in this area suggests that multidisciplinary wound care team may significantly improve healing in the acute care setting in 8 weeks and may significantly shorten the length of hospitalization. However, since only an abstract is available, study biases cannot be assessed and no conclusion can be drawn on the quality of this evidence.
Based on analyses of the evidence, the following conclusion can be drawn:
  • Evidence is generally based on small RCTs with methodological flaws.
  • The type of nonsurgical debridement used did not appear to have a significant impact on the complete healing of ulcers.
  • No significant differences in debridement abilities were detected among nonsurgical debridement agents with the following exceptions:
    • Papain urea results in better debridement than collagenase.
    • Calcium alginate resulted in better debridement than dextranomer.
    • The addition of streptokinase/streptodornase improved the debridement ability of hydrogel.
  • There were no significant differences among modern dressings in influencing complete healing of pressure ulcers except:
    • Hydrocolloid dressing was associated with significantly more complete healing than saline gauze (5–12 weeks).
    • Hydrogel or hydropolymer was associated with more complete healing compared with hydrocolloid dressing.
  • There is evidence that polyurethane foam dressing and hydrocellular dressing have better absorbency and less difficult removal compared with hydrocolloid dressings.
  • Efficacy of topical growth factors in treating pressure ulcer has not been established. The use of PDGF has been associated with higher mortality from cancers.
  • There were no significant differences in complete healing between specialized beds and mattresses except:
    • An AP bed with a heel guard improved healing of heel ulcers compared with alternating bed without a heel guard.
    • Profiling beds were superior to flat-based beds.
    • Air-fluidized beds were associated with significantly more improved ulcers compared with other low pressure beds or mattresses.
  • Supplementation of standard hospital diet with protein, ascorbic acid (500 mg twice daily), or multinutrient supplements was associated with a significantly greater or faster reduction in the size of pressure ulcers, but did not result in a significant increase in the proportion of healed pressure ulcers.
  • There is evidence that suggests electrotherapy may improve healing of pressure ulcers; however, no firm conclusion can be drawn. There is no evidence at this time that other adjunctive physical therapies (electromagnetic therapy, ultrasound therapy, ultrasound therapy in conjunction with ultraviolet C light, LLL therapy, and NPWT) would improve the healing of pressure ulcers.
  • There is preliminary evidence that suggests multidisciplinary wound care teams may have an impact on the healing of pressure ulcers and length of hospitalization in the acute care setting; however, no firm conclusion can be drawn at this time.
AlginateA salt of alginic acid, a colloidal substance from brown seaweed; used, in the form of calcium, sodium, or ammonium alginate, as foam, clot, or gauze for absorbable surgical dressings.
AngiogenesisThe formation of new blood vessels.
AntimicrobialAn agent that kills bacteria or suppresses their multiplication or growth, including antibiotics and synthetic agents.
Ascorbic AcidThe chemical name for vitamin C.
AutolysisThe term used for the natural, spontaneous process of devitalized tissue being separated from viable tissue.
Braden ScaleA tool for assessing a person’s risk for developing pressure ulcers.
Cadexomer iodineAn antiseptic that consists of spherical hydrophilic microbeads of modified starch, which contain iodine, is highly absorbent, and releases iodine slowly in the wound area.
Calcium AlginateCalcium alginate is the calcium salt of alginic acid.
ChemotaxisThe phenomenon in which bodily cells, bacteria, and other single-cell or multicellular organisms direct their movements according to certain chemicals in their environment. For example, neutrophils migrating towards bacteria based on recognition of chemicals produced by the bacteria.
CollagenThe principal protein of the skin, tendons, cartilage, bone, and connective tissue.
CollagenaseAn enzyme formed when the skin is irritated or inflamed. Collagenase breaks down the collagen fibers in the dermis.
DebridementThe removal of necrotic or infected tissues and excess moisture from a wound that may impair proper wound healing
DextranomerA sterile, insoluble powder in the form of circular beads, that are highly hydrophilic, drawing moisture away from the wound surface by capillary action, and is also capable of drawing nonviable debris from the wound bed.
Electromagnetic StimulationThe use of pulsed electromagnetic fields in the radiofrequency band without thermal effects. It does not involve the use of current, leads, or electrodes.
Endothelial CellsHighly specialized cells that line the endothelium. They are polygonal in shape and joined together by tight junctions. The tight junctions allow for variable permeability to specific macromolecules that are transported across the endothelial layer.
EpithelializationThe final stage of the proliferative phase of healing where skin forms over a wound.
EschcarA thick, coagulated crust or slough which develops following a thermal burn or chemical or physical cauterization of the skin.
ExudateA fluid with a high content of protein and cellular debris which has escaped from blood vessels and has been deposited in tissues or on tissue surfaces, usually as a result of inflammation.
FibroblastCommon cell type, found in connective tissue, that secretes an extracellular matrix rich in collagen and other macromolecules. Migrates and proliferates readily in wound repair and in tissue culture.
Growth FactorsAre cytokines (chemical signals) that control cell growth, cell migration, matrix production, enzyme expression, and differentiation. They play fundamental roles in the wound repair process
GranulationThat part of the healing process in which rough, pink tissue containing new connective tissue and capillaries forms around the edges of a wound. Granulation of a wound is normal and desirable.
HydrocolloidA waterproof, occlusive dressing that consists of a mixture of pectins, gelatins, sodium carboxymethylcellulose, and elastomers. Hydrocolloids create an environment that encourages autolysis to debride wounds that are sloughy or necrotic.
HydrogelA colloid in which the particles are in the external or dispersion phase and water us in the internal or dispersed phase. Gels have a high water content, which aids the rehydration of hard eschar and promotes autolysis in necrotic wounds.
HydrolyzedTo undergo hydrolysis which is a chemical reaction or process in which a chemical compound reacts with water. This type of reaction is used to break down polymers.
Hydropolymer DressingHighly absorbent polyurethane dressing consisting of a vapour-permeable foam matrix.
HydrotherapyIs the use of water in any of its 3 forms (solid, liquid, or gas), internally or externally, for the treatment of disease and trauma or for cleansing purposes.
HypergranulationGranulation tissue that is raised above the periwound area.
KeratinocyteStratified, squamous, epithelial cells which comprise skin and mucosa; provide a barrier between the host and the environment; prevent the entry of toxic substances from the environment and the loss of important constituents from the host; differentiate as they progress from the basal layer to the skin surface.
MacerationA softening or sogginess of the tissue due to retention of excessive moisture which presents as moist, red/white, and wrinkled.
MacrophagesA type of white blood cell that engulfs and destroys foreign materials. They are the key players in the immune response to foreign invaders such as infectious microorganisms.
Matrix MetalloproteasesA member of a group of enzymes that can break down proteins, such as collagen, that are normally found in the spaces between cells in tissues (i.e., extracellular matrix proteins). Because these enzymes need zinc or calcium atoms to work properly, they are called metalloproteinases. Matrix metalloproteinases are involved in wound healing, angiogenesis, and tumor cell metastasis.
NecroticThe local death of tissue. This tissue is often black/brown in colour and leathery in texture.
Nerve Growth FactorA polypeptide that has been shown to promote the regeneration of injured cells that express nerve growth factor receptors in the peripheral and central nervous systems.
NeutrophilA white blood cell that plays a central role in defence of a host against infection. Neutrophils engulf and kill foreign microorganisms.
NitrofurazoneA pale yellow crystalline compound used externally as a bacteriostatic or bactericidal dressing for wounds and infections.
NormothermicA condition of normal body temperature.
PeriwoundThe area immediately around the wound.
PhenytoinIs an antiepileptic agent that when used topically has shown to accelerate the healing process in ulcers of various etiology.
Platelet-Derived Growth Factor (PDGF)A mitogenic growth factor that is found especially in platelets, consists of 2 polypeptide chains linked by bonds containing 2 sulfur atoms each, stimulates cell proliferation (as in connective tissue, smooth muscle, and glia), and plays a role in wound healing
PolyurethaneA synthetic resin in which the polymer units are linked by urethane groups, used chiefly as constituents of paints, varnishes, adhesives, and foams.
Pressure Sore Status Tool (PSST)A tool used to quantify the wound healing process. This tool assesses a pressure ulcer condition based on 13 parameters each measured on a Likert scale of 1 to 5. The total score ranges from 13 to 65 with the score of 13 indicating a healed ulcer.
Pressure UlcerA localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction.
Pressure Ulcer Scale for Healing (PUSH)Scores a pressure ulcer based on its surface area, amount of exudates, and the type of tissue present (e.g., granulation). The total score ranges from 0 (healed ulcer) to 17 (>24 cm2 with heavy exudates and necrosis).
ProliferationWhen new granulation tissue is formed to replace lost volume. Epithelial cells grow around the wound, or in islets, to form a new protective covering.
SloughA term for the viscous yellow layer which often covers the wound and is strongly adherent to it. Its presence can be related to the end of the inflammatory stage of healing when dead cells have accumulated in the exudate.
StreptodornaseLiquefies the vicious nucleoprotein of dead cells or pus.
StreptokinaseA clot-dissolving medication.
WoundA break in the integrity of the skin; an injury to the body which causes a disruption of the normal continuity of the body structures.

Appendices
Appendix 1: U.S. National Pressure Ulcer Advisory Panel Staging System (1)
StageDefinitionFurther description
Suspected Deep Tissue InjuryPurple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared with adjacent tissue.Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid exposing additional layers of tissue even with optimal treatment.
Stage IIntact skin with nonblanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area.The area may be painful, firm, soft, warmer or cooler as compared with adjacent tissue. Stage I may be difficult to detect in individuals with dark skin tones. May indicate “at risk” persons (a heralding sign of risk)
Stage IIPartial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.Presents as a shiny or dry shallow ulcer without slough or bruising.* This stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation.
Stage IIIFull thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling.The depth of a stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers. Bone/tendon is not visible or directly palpable.
Stage IVFull thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling.The depth of a stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable.
UnstageableFull thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as “the body's natural (biological) cover” and should not be removed.
*Bruising indicates suspected deep tissue injury
Appendix 2: Summary of Studies on Factors That Predict Healing of Pressure Ulcers*
Jones 2007Bergstrom 2005Kramer 2000Berlowitz 1997
DesignMulticentre retrospective cohort studyMulticentre retrospective cohort studySingle centre retrospective cohort studyMulticentre retrospective cohort study
SettingPressure ulcer care in hospitals, clinics, nursing homes and home care in 3 geographical areas95 Long-term care facilitiesChronic unit of one long-term care facilityLong-term care facilities in the United States
Sample size82882106819
Study period6 months12 weeks4 weeks6 months
Mean age, years78.0Stage II Stage III/IV
79.8      76.0 (P < .002)
66.870.4
Caucasian, %59.3NR65NR
Ulcer, %Stage II 76.5
Stage III 33.3
Stage IV 13.3
Stage II      68
Stage III/IV 32
Stage II 21
Stage III 14
Stage IV 65
Stage II NR
Stage III NR
Stage IV 22.3
Source of dataReview of medical records
Structured form
Review of medical records, Medical Data Set, and other recordsMedical recordsVeterans Affairs Assessment File
Statistical analysis-Chi square, F-tests
-Student t test
-Variance analysis
-Forward and backward conditional multiple regression modelling
2 multiple regression models:
One for stage II ulcers and 1 for stage II/III ulcers
-Correlation analysis
-Forward multiple regression modelling
Bivariate analysis
Multiple logistic regression modelling
Measure of healingComplete healing, %Complete healing, %Decrease in surface area of ulcer, %
Mean = 35.6
Complete healing, %
3 mos6 mos12 weeksOverall54
Stage II27.376.5Stage II37Stage II72
Stage III10.233.3Stage III/IV5Stage III45.2
Stage IV2.613.3Stage IV30.6
Between stages (P < .001)
Performance of multivariate regression modelBackward conditional model Significant (P < .001) Explained 75.8 of the variance of healing Predicted correctly 91.5% of casesModel for stage II ulcers
Explained little of the variance (R = 0.13)
3 predictors explained 25% of the variability in healing
Factors associated with ↑ odds of healingUse of exudate management dressing with no exudateAssociated with greatest ↓ in area of ulcer
Stage II ulcers
-Dementia and agitation without hallucination
-↑ in interval of assessment
-Very large ulcers
-Moist dressing
Stage III/IV ulcers
-Dementia
-Very large pressure ulcers ≥ 12cm
-Receiving sufficient enteral feeding >30kcal/kg
(except high acuity patients)
-Moist dressing
-Lower pressure ulcer stage
-Higher patient weight
-Lower mean body temperature
Together predictors explained 25% of the variability in healing

In a regression analysis of treatment variables, only shorter time on a pressure ulcer-relieving bed predicted healing
-Age >75 years
(OR, 1.5 [95% CI, 1.1–2.0])
-Stage II ulcer vs stage IV
(OR, 5.2 [95% CI, 3.5])
-Rehabilitation services (per number received) (OR, 1.3 [95% CI, 1.1–1.6])
Factors associated with ↓ odds of healing-Medicaid
(OR, 0.18, P = .087)
-Comorbid CVD
(OR, 0.14, P = .063)
-Dressing type change
(OR = 0.50, P = .015)
-Topical antiseptics
-Antibiotic administration
-Pressure relief devices
-No exudate management dressing for moderate or large amount of exudate
-No debridement of wounds with yellow slough
Stage II ulcers
Cleaning with saline or soap
Stage III/IV
Receiving debridement
-High pressure ulcer stage
-Low patient weight
-High patient temperature
-Incontinence
(OR, 0.7 [95% CI, 0.4–1.0])
-Immobility
(OR, 0.3 [95% CI, 0.1–0.5])
*CI, confidence interval; NR, not reported; OR, odds ratio
Appendix 3: Search Strategies
Pressure Sores Treatment – Final Search
Search date: August 6, 2007
Databases searched: OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, CINAHL, EMBASE, Cochrane Library, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to July Week 4 2007>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/dh, dt, rt, rh, su, th [Diet Therapy, Drug Therapy, Radiotherapy, Rehabilitation, Surgery, Therapy] (905)
  • exp Pressure Ulcer/ or exp Skin Ulcer/ or (decubitus or bedsore$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (12589)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6443)
  • 2 or 3 (13597)
  • exp Nutritional Support/ or exp Dietary Supplements/ or exp Nutrition/ (26310)
  • Debridement/ or exp Irrigation/ or exp Suction/ or exp Bandages/ or exp Beds/ or exp pressure/ or exp Larva/ (55505)
  • (Platelet releasate or CT-102).mp. (48)
  • exp Stem Cells/ (70804)
  • exp Therapeutics/ (908746)
  • exp Surgery/ (8437)
  • exp Skin Transplantation/ or exp Skin, Artificial/ (6047)
  • exp Treatment Outcome/ (275526)
  • exp Treatment Failure/ (13032)
  • exp Hydrotherapy/ or exp Ultrasonic Therapy/ or exp Ultraviolet Therapy/ or exp Electric Stimulation Therapy/ or exp Electromagnetics/ (23802)
  • wound bed prep$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (66)
  • exp Transforming Growth Factor beta/ or exp Growth Substances/ or exp Fibroblast Growth Factors/ or exp Platelet-Derived Growth Factor/ or exp Epidermal Growth Factor/ or exp Colony-Stimulating Factors/ (248588)
  • ((wound$ or ulcer$) adj3 (modulat$ or growth factor$ or stimulating factor$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (603)
  • or/5-17 (1388534)
  • 4 and 18 (6644)
  • 1 or 19 (6987)
  • limit 20 to (humans and english language and yr=“1996 - 2007”) (5718)
  • limit 21 to (controlled clinical trial or meta analysis or randomized controlled trial) (555)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (53354)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (319845)
  • exp Double-Blind Method/ or exp Control Groups/ or exp placebos/ or RCT$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (55363)
  • exp Economics/ (172912)
  • (cost$ or economic$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (190006)
  • or/22-27 (614901)
  • 21 and 28 (1377)
  • exp Diabetes Mellitus/ (95945)
  • exp Burns/ (10893)
  • exp Varicose Ulcer/ (1188)
  • exp Diabetic Angiopathies/ (12924)
  • or/30-33 (107894)
  • 29 not 34 (875)
 
Database: EMBASE <1980 to 2007 Week 30>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/rt, dm, rh, dt, su, th [Radiotherapy, Disease Management, Rehabilitation, Drug Therapy, Surgery, Therapy] (1088)
  • exp skin ulcer/ or exp decubitus/ (16832)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (8942)
  • (decubitus or bedsore$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (4887)
  • or/2-4 (19305)
  • exp nutrition/ or exp diet therapy/ or exp nutritional support/ (779276)
  • exp diet supplementation/ (25678)
  • exp LAVAGE/ (26658)
  • exp SUCTION/ (1566)
  • exp Bandage/ (1531)
  • exp “BANDAGES AND DRESSINGS”/ (9345)
  • exp bed/ (2384)
  • exp PRESSURE/ (24926)
  • wound care/ or debridement/ or maggot therapy/ or wound drainage/ or wound dressing/ or wound irrigation/ (17158)
  • exp Stem Cell/ (41237)
  • exp Therapy/ (2500403)
  • exp surgery/ (1328439)
  • exp Skin Transplantation/ (20591)
  • exp Artificial Skin/ (405)
  • exp Treatment Outcome/ (389424)
  • exp Treatment Failure/ (34266)
  • exp hydrotherapy/ or exp electrostimulation therapy/ or exp ultrasound therapy/ (78822)
  • exp phototherapy/ (20784)
  • exp Electromagnetic Field/ (5101)
  • exp Patient Positioning/ (6574)
  • exp Growth Factor/ (180173)
  • ((wound$ or ulcer$) adj3 (modulat$ or growth factor$ or stimulating factor$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (1883)
  • (Platelet releasate or CT-102).mp. (58)
  • wound bed prep$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (56)
  • or/6-29 (3941237)
  • 5 and 30 (13134)
  • 1 or 31 (13288)
  • limit 32 to (human and english language and yr=“1996 – 2007”) (7329)
  • Randomized Controlled Trial/ (121547)
  • exp Randomization/ (23112)
  • exp RANDOM SAMPLE/ (692)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).ti,mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (74484)
  • Double Blind Procedure/ (64908)
  • exp Triple Blind Procedure/ (7)
  • exp Control Group/ (902)
  • exp PLACEBO/ (101571)
  • exp ECONOMICS/ (12565)
  • (cost$ or economic$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (324903)
  • or/34-43 (599075)
  • 33 and 44 (1289)
  • exp Diabetes Mellitus/ (206434)
  • exp Burn/ (21386)
  • exp Varicosis/ (15726)
  • or/46-48 (243034)
  • 45 not 49 (732)
 
Database: CINAHL - Cumulative Index to Nursing & Allied Health Literature <1982 to July Week 4 2007>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/dh, dt, rh, su, th [Diet Therapy, Drug Therapy, Rehabilitation, Surgery, Therapy] (1098)
  • exp skin ulcer/ or exp pressure ulcer/ or (decubitus or bedsore$).mp. [mp=title, subject heading word, abstract, instrumentation] (9542)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6067)
  • exp NUTRITION/ (31831)
  • exp Nutritional Support/ (12258)
  • exp Dietary Supplements/ (1721)
  • exp Debridement/ (1363)
  • exp Irrigation/ (1560)
  • exp SUCTION/ (1152)
  • exp “Bandages and Dressings”/ (4922)
  • exp “Beds and Mattresses”/ (1763)
  • exp Pressure/ (1842)
  • exp Patient Positioning/ (3886)
  • exp Stem Cells/ (1757)
  • exp Therapeutics/ (346621)
  • exp Surgery, Operative/ (87954)
  • exp Skin, Artificial/ (309)
  • exp Skin Transplantation/ (825)
  • exp Treatment Outcomes/ (38071)
  • exp Treatment Failure/ (2064)
  • electrotherapy/ or hydrotherapy/ or ultrasonic therapy/ or ultraviolet therapy/ (1483)
  • exp Electromagnetics/ or exp Magnet Therapy/ (1015)
  • exp Growth Substances/ (5215)
  • ((wound$ or ulcer$) adj3 (modulat$ or growth factor$ or stimulating factor$)).mp. [mp=title, subject heading word, abstract, instrumentation] (172)
  • (Platelet releasate or CT-102).mp. (5)
  • wound bed prep$.mp. [mp=title, subject heading word, abstract, instrumentation] (78)
  • 2 or 3 (10021)
  • or/4-26 (440839)
  • 27 and 28 (6279)
  • 1 or 29 (6500)
  • limit 30 to (english and yr=“1996 – 2007”) (5101)
  • exp Diabetes Mellitus/ (26976)
  • exp BURNS/ (5684)
  • exp Venous Ulcer/ (788)
  • or/32-34 (33319)
  • 31 not 35 (3103)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (58616)
  • RCT.mp. (680)
  • exp Meta Analysis/ (5479)
  • exp “Systematic Review”/ (3217)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (19079)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (11176)
  • exp PLACEBOS/ (3668)
  • exp Economics/ (215909)
  • (economic$ or cost$).mp. [mp=title, subject heading word, abstract, instrumentation] (54062)
  • or/37-45 (280064)
  • 36 and 46 (885)
 
Final Search Strategy – Pressure Sores 2008 - Cleaning
Search date: March 19, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • exp Skin Ulcer/ (12547)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Irrigation/ (6280)
  • exp Hydrotherapy/ (418)
  • exp Solutions/ (33578)
  • exp Water/ (65110)
  • exp Sodium Chloride/ (15190)
  • exp Anti-Infective Agents, Local/ (52642)
  • exp acetic acids/ or acetic acid/ (32800)
  • exp Disinfection/ (3099)
  • exp Potassium Permanganate/ or exp Gentian Violet/ (943)
  • exp Surface-Active Agents/ (28536)
  • exp Castor Oil/ (293)
  • (detergent$ or whirlpool$ or saline or povidone or iodine or disinfect$ or bath$ or water or hydrotherap$ or hydro-therap$ or lavage or irrigat$ or wash$ or cleans$ or clean$ or aloe vera or gentian violet or eusol or potassium permanganate or benzoyl peroxide or hyrogen peroxide or betadine or silver chloride or vulnopur or decyl glucoside).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346012)
  • or/7-18 (460724)
  • 6 and 19 (4023)
  • limit 20 to (english language and humans and yr=“2003 – 2008”) (1178)
  • limit 21 to (controlled clinical trial or meta analysis or randomized controlled trial) (219)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/22-29 (414777)
  • 21 and 30 (321)
  • exp *Burns/ (9607)
  • *Diabetic Foot/ (2580)
  • *Ischemia/ (8409)
  • *Surgical Wound Infection/ (4370)
  • *Postoperative Complications/ (37461)
  • *Varicose Ulcer/ (1075)
  • or/32-37 (62828)
  • 31 not 38 (182)
 
Database: EMBASE <1980 to 2008 Week 11>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3882)
  • exp Skin Ulcer/ (17884)
  • exp Wound Healing/ or exp Wound Infection/ (50625)
  • exp Chronic Wound/ (227)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9428)
  • bedsore$.mp. (154)
  • or/1-6 (67100)
  • exp WOUND IRRIGATION/ (605)
  • exp HYDROTHERAPY/ (1143)
  • exp “Solution and Solubility”/ (66832)
  • exp WATER/ (110563)
  • exp Sodium Chloride/ (52921)
  • exp Hydrogen Peroxide/ (27914)
  • exp Topical Antiinfective Agent/ (104248)
  • exp Acetic Acid/ (16793)
  • exp DISINFECTION/ (8510)
  • exp Permanganate Potassium/ (1258)
  • exp Surfactant/ (79380)
  • exp Castor Oil/ (1021)
  • (detergent$ or whirlpool$ or saline or povidone or iodine or disinfect$ or bath$ or water or hydrotherap$ or hydro-therap$ or lavage or irrigat$ or wash$ or cleans$ or clean$ or aloe vera or gentian violet or eusol or potassium permanganate or benzoyl peroxide or hyrogen peroxide or betadine or silver chloride or vulnopur or decyl glucoside).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (612905)
  • or/8-20 (807447)
  • 7 and 21 (6982)
  • limit 22 to (human and english language and yr=“2003 - 2008”) (1703)
  • Randomized Controlled Trial/ (155511)
  • exp Randomization/ (25203)
  • exp RANDOM SAMPLE/ (1011)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (280926)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56808)
  • Double Blind Procedure/ (68576)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1516)
  • exp PLACEBO/ (111054)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (402720)
  • or/24-33 (612781)
  • 23 and 34 (312)
  • *Burns/ (12425)
  • *Diabetic Foot/ (1980)
  • *Varicosis/ (3636)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10581)
  • or/36-40 (28645)
  • 35 not 41 (256)
 
Database: CINAHL - Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5153)
  • exp Wound Healing/ or exp Wound Infection/ (9484)
  • exp Skin Ulcer/ (10197)
  • exp Wounds, Chronic/ (826)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6554)
  • bedsore$.mp. (75)
  • or/1-6 (18277)
  • exp IRRIGATION/ (1765)
  • exp HYDROTHERAPY/ (878)
  • exp SOLUTIONS/ (3029)
  • exp WATER/ (1697)
  • exp Sodium Chloride/ (1161)
  • exp Hydrogen Peroxide/ (290)
  • exp ANTIINFECTIVE AGENTS, LOCAL/ (2858)
  • exp Acetic Acid/ (205)
  • exp “Sterilization and Disinfection”/ (3167)
  • exp Surface-Active Agents/ (563)
  • (detergent$ or whirlpool$ or saline or povidone or iodine or disinfect$ or bath$ or water or hydrotherap$ or hydro-therap$ or lavage or irrigat$ or wash$ or cleans$ or clean$ or aloe vera or gentian violet or eusol or potassium permanganate or benzoyl peroxide or hyrogen peroxide or betadine or silver chloride or vulnopur or decyl glucoside).mp. [mp=title, subject heading word, abstract, instrumentation] (31568)
  • exp Castor Oil/ (26)
  • or/8-19 (36072)
  • 7 and 20 (1331)
  • limit 21 to (english and yr=“2003 - 2008”) (598)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69213)
  • RCT.mp. (872)
  • exp Meta Analysis/ (6294)
  • exp “Systematic Review”/ (3554)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22852)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13890)
  • exp PLACEBOS/ (4185)
  • or/23-29 (90540)
  • 22 and 30 (130)
Final Search – Pressure Sores 2008 - Debridement
Search date: March 22, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Debridement/ (4526)
  • debrid$.mp. (8618)
  • exp Larva/ (14177)
  • exp Streptokinase/ (1402)
  • exp Iodine Compounds/ or exp Hydrogel/ (4077)
  • (trypsin or varidase or enzym$ or chemical$ or autolytic or collagenase or streptokinase or dextranoma or streptodornase or papain-urea or cadexomer iodine or larva$ or maggot$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (668012)
  • (polysaccharide$ or dextranomer$ or xerogel).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (20260)
  • (biosurger$ or bio-surg$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (39)
  • (hydrocolloid* or granuflex or tegasorb or aquacel or hydrocoll or combiderm or duoderm).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (634)
  • (fibrinolytic$ or proteolytic or hypochlorite or dakin or iodoflex or iodosorb or debrisan or eusol).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (35932)
  • (malic acid or benzoid acid or salicylic acid or propylene glycol).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (5193)
  • (hydrogel$ or intrasite gel$ or intrasitgel$ or sterigel or granugel or nugel or purilon or vigilon).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (4770)
  • or/7-18 (722998)
  • 6 and 19 (5341)
  • limit 20 to (english language and humans and yr=“2003 - 2008”) (1823)
  • limit 21 to (controlled clinical trial or meta analysis or randomized controlled trial) (169)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/22-29 (414778)
  • 21 and 30 (262)
  • *Diabetic Foot/ (2580)
  • *Burns/ (7235)
  • *Ischemia/ (8409)
  • *Surgical Wound Infection/ (4370)
  • *Postoperative Complications/ (37461)
  • *Varicose Ulcer/ (1075)
  • or/32-37 (60476)
  • 31 not 38 (163)
  • limit 39 to (case reports or comment or letter) (6)
  • 39 not 40 (157)
 
Database: EMBASE <1980 to 2008 Week 12> Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Wound Healing/ or exp Wound Infection/ (50688)
  • exp Chronic Wound/ (229)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9444)
  • bedsore$.mp. (155)
  • or/1-6 (67188)
  • exp WOUND IRRIGATION/ (606)
  • exp HYDROTHERAPY/ (1144)
  • exp “Solution and Solubility”/ (66942)
  • exp WATER/ (110696)
  • exp Sodium Chloride/ (53001)
  • exp Hydrogen Peroxide/ (27975)
  • exp Topical Antiinfective Agent/ (104398)
  • exp Acetic Acid/ (16817)
  • exp DISINFECTION/ (8516)
  • exp Permanganate Potassium/ (1260)
  • exp Surfactant/ (79483)
  • exp Castor Oil/ (1022)
  • (detergent$ or whirlpool$ or saline or povidone or iodine or disinfect$ or bath$ or water or hydrotherap$ or hydro-therap$ or lavage or irrigat$ or wash$ or cleans$ or clean$ or aloe vera or gentian violet or eusol or potassium permanganate or benzoyl peroxide or hyrogen peroxide or betadine or silver chloride or vulnopur or decyl glucoside).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (613582)
  • or/8-20 (808382)
  • 7 and 21 (6992)
  • limit 22 to (human and english language and yr=“2003 - 2008”) (1708)
  • Randomized Controlled Trial/ (155780)
  • exp Randomization/ (25236)
  • exp RANDOM SAMPLE/ (1022)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281365)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56961)
  • Double Blind Procedure/ (68653)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1545)
  • exp PLACEBO/ (111315)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403354)
  • or/24-33 (613798)
  • 23 and 34 (312)
  • *Burns/ (12430)
  • *Diabetic Foot/ (1981)
  • *Varicosis/ (3637)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10590)
  • or/36-40 (28661)
  • 35 not 41 (256)
  • limit 42 to (editorial or letter or note) (13)
  • Case Report/ (983221)
  • 42 not (43 or 44) (235)
 
Database: CINAHL - Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5153)
  • exp Skin Ulcer/ (10197)
  • exp Wounds, Chronic/ (826)
  • exp Wound Healing/ or exp Wound Infection/ (9484)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6554)
  • bedsore$.mp. (75)
  • or/1-6 (18277)
  • exp DEBRIDEMENT/ (1619)
  • exp Streptokinase/ (249)
  • exp Larval Therapy/ (180)
  • exp Iodine Compounds/ (139)
  • exp HYDROGEL DRESSINGS/ (269)
  • debrid$.mp. (2318)
  • (trypsin or varidase or enzym$ or chemical$ or autolytic or collagenase or streptokinase or dextranoma or streptodornase or papain-urea or cadexomer iodine or larva$ or maggot$).mp. [mp=title, subject heading word, abstract, instrumentation] (20077)
  • (polysaccharide$ or dextranomer$ or xerogel).mp. [mp=title, subject heading word, abstract, instrumentation] (632)
  • (hydrocolloid* or granuflex or tegasorb or aquacel or hydrocoll or combiderm or duoderm).mp. [mp=title, subject heading word, abstract, instrumentation] (461)
  • (biosurger$ or bio-surg$).mp. [mp=title, subject heading word, abstract, instrumentation] (10)
  • (fibrinolytic$ or proteolytic or hypochlorite or dakin or iodoflex or iodosorb or debrisan or eusol).mp. [mp=title, subject heading word, abstract, instrumentation] (2030)
  • (malic acid or benzoid acid or salicylic acid or propylene glycol).mp. [mp=title, subject heading word, abstract, instrumentation] (65)
  • (hydrogel$ or intrasite gel$ or intrasitgel$ or sterigel or granugel or nugel or purilon or vigilon).mp. [mp=title, subject heading word, abstract, instrumentation] (389)
  • or/8-20 (25090)
  • 7 and 21 (1766)
  • limit 22 to (english and yr=“2003 - 2008”) (840)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69213)
  • RCT.mp. (872)
  • exp Meta Analysis/ (6294)
  • exp “Systematic Review”/ (3554)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22852)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13890)
  • exp PLACEBOS/ (4185)
  • or/24-30 (90540)
  • 23 and 31 (100)
  • *Burns/ (4636)
  • *Diabetic Foot/ (1954)
  • *Surgical Wound/ or exp Postoperative Complications/ (17091)
  • *Ischemia/ (645)
  • *Venous Ulcer/ (625)
  • or/33-37 (24822)
  • 32 not 38 (53)
Final Search – Pressure Sores - Dressings
Search date: March 16, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 1 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3480)
  • exp Wound Healing/ or exp Wound Infection/ (33963)
  • exp Skin Ulcer/ (12499)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6897)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1422)
  • or/1-5 (45284)
  • exp Bandages/ (6673)
  • ((gauze$ or dressing$ or bandage$) adj4 (biological or collagen or growth factor$ or hyaluronic acid$ or interleukin$ or stimulat$ factor$ or hydrocolloid$ or hydrogel$ or carboxymethylcellulose or hydropolymer or hydrocellular or alginate or normothermic or film$ or foam$ or antimicrobial$ or silver$ or honey or iodine or chorhexidine or polyurethane or fabric$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1377)
  • 7 or 8 (6880)
  • 6 and 9 (3093)
  • limit 10 to (english language and humans and yr=“2003 - 2008”) (1180)
  • limit 11 to (controlled clinical trial or meta analysis or randomized controlled trial) (191)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31320)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59263)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (345174)
  • exp Double-Blind Method/ (50275)
  • exp Control Groups/ (532)
  • exp Placebos/ (8713)
  • RCT.mp. (2232)
  • or/12-19 (413674)
  • 11 and 20 (333)
  • *Burns/ (7225)
  • *Diabetic Foot/ (2565)
  • *Varicose Ulcer/ (1073)
  • *Ischemia/ (8391)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41550)
  • or/22-26 (60362)
  • 21 not 27 (205)
  • limit 28 to (case reports or comment or editorial or letter) (24)
  • 28 not 29 (181)
 
Database: EMBASE <1980 to 2008 Week 11>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3882)
  • exp Skin Ulcer/ (17884)
  • exp Wound Healing/ or exp Wound Infection/ (50625)
  • exp Chronic Wound/ (227)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9428)
  • bedsore$.mp. (154)
  • or/1-6 (67100)
  • exp “bandages and dressings”/ (9947)
  • ((gauze$ or dressing$ or bandage$) adj4 (biological or collagen or growth factor$ or hyaluronic acid$ or interleukin$ or stimulat$ factor$ or hydrocolloid$ or hydrogel$ or carboxymethylcellulose or hydropolymer or hydrocellular or alginate or normothermic or film$ or foam$ or antimicrobial$ or silver$ or honey or iodine or chorhexidine or polyurethane or fabric$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (1422)
  • 8 or 9 (10334)
  • 7 and 10 (3144)
  • limit 11 to (human and english language and yr=“2003 - 2008”) (1072)
  • Randomized Controlled Trial/ (155511)
  • exp Randomization/ (25203)
  • exp RANDOM SAMPLE/ (1011)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (280926)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56808)
  • Double Blind Procedure/ (68576)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1516)
  • exp PLACEBO/ (111054)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (402720)
  • or/13-22 (612781)
  • 12 and 23 (247)
  • *Burn/ (12425)
  • *Diabetic Foot/ (1980)
  • *Varicosis/ (3636)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10581)
  • or/25-29 (28645)
  • 24 not 30 (178)
  • limit 31 to (editorial or letter or note) (16)
  • Case Report/ (982316)
  • 31 not (32 or 33) (158)
 
Database: CINAHL - Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 1 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5128)
  • exp Skin Ulcer/ (10126)
  • exp Wounds, Chronic/ (817)
  • exp Wound Healing/ or exp Wound Infection/ (9366)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6512)
  • bedsore$.mp. (74)
  • or/1-6 (18089)
  • exp “Bandages and Dressings”/ (5335)
  • ((gauze$ or dressing$ or bandage$) adj4 (biological or collagen or growth factor$ or hyaluronic acid$ or interleukin$ or stimulat$ factor$ or hydrocolloid$ or hydrogel$ or carboxymethylcellulose or hydropolymer or hydrocellular or alginate or normothermic or film$ or foam$ or antimicrobial$ or silver$ or honey or iodine or chorhexidine or polyurethane or fabric$)).mp. [mp=title, subject heading word, abstract, instrumentation] (1568)
  • 8 or 9 (5419)
  • 7 and 10 (2689)
  • limit 11 to (english and yr=“2003 - 2008”) (1124)
  • *Burns/ (4584)
  • *Diabetic Foot/ (1931)
  • *Surgical Wound/ or exp Postoperative Complications/ (16692)
  • *Ischemia/ (618)
  • *Venous Ulcer/ (619)
  • or/13-17 (24318)
  • 12 not 18 (748)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (67992)
  • RCT.mp. (858)
  • exp Meta Analysis/ (6223)
  • exp “Systematic Review”/ (3535)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22492)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13554)
  • exp PLACEBOS/ (4145)
  • or/20-26 (88939)
  • 19 and 27 (67)
Final Search Strategy – Pressure Sores 2008 - Growth Factors
Search date: March 19, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 1 2008> Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3480)
  • exp Wound Healing/ or exp Wound Infection/ (33963)
  • exp Skin Ulcer/ (12499)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6897)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1422)
  • or/1-5 (45284)
  • exp “Intercellular Signaling Peptides and Proteins”/ (343648)
  • exp Growth Substances/ (192006)
  • ((growth or stimulat$) adj2 (substance$ or factor$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (169667)
  • interleukin$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (110693)
  • or/7-10 (555006)
  • 6 and 11 (5613)
  • limit 12 to (english language and humans and yr=“2003 - 2008”) (1628)
  • limit 13 to (controlled clinical trial or meta analysis or randomized controlled trial) (74)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31320)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59263)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (345174)
  • exp Double-Blind Method/ (50275)
  • exp Control Groups/ (532)
  • exp Placebos/ (8713)
  • RCT.mp. (2232)
  • or/14-21 (413657)
  • 13 and 22 (153)
  • *Burns/ (7225)
  • *Diabetic Foot/ (2565)
  • *Varicose Ulcer/ (1073)
  • *Ischemia/ (8391)
  • *Postoperative Complications/ (37401)
  • *Surgical Wound Infection/ (4359)
  • or/24-29 (60362)
  • 23 not 30 (107)
  • limit 31 to (case reports or comment or editorial or letter) (12)
  • 31 not 32 (95)
 
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3882)
  • exp Skin Ulcer/ (17884)
  • exp Wound Healing/ or exp Wound Infection/ (50625)
  • exp Chronic Wound/ (227)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9428)
  • bedsore$.mp. (154)
  • or/1-6 (67100)
  • exp Growth Factor/ (192755)
  • exp Cytokine/ (469215)
  • ((growth or stimulat$) adj2 (substance$ or factor$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (254180)
  • or/8-10 (599116)
  • 7 and 11 (8126)
  • limit 12 to (human and english language and yr=“2003 - 2008”) (2520)
  • Randomized Controlled Trial/ (155511)
  • exp Randomization/ (25203)
  • exp RANDOM SAMPLE/ (1011)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (280926)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56808)
  • Double Blind Procedure/ (68576)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1516)
  • exp PLACEBO/ (111054)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (402720)
  • or/14-23 (612781)
  • 13 and 24 (397)
  • *Burn/ (12425)
  • *Diabetic Foot/ (1980)
  • *Varicosis/ (3636)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10581)
  • or/26-30 (28645)
  • 25 not 31 (357)
  • limit 32 to (editorial or letter or note) (22)
  • Case Report/ (982316)
  • 32 not (33 or 34) (331)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5153)
  • exp Skin Ulcer/ (10197)
  • exp Wounds, Chronic/ (826)
  • exp Wound Healing/ or exp Wound Infection/ (9484)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6554)
  • bedsore$.mp. (75)
  • or/1-6 (18277)
  • exp Cytokines/ (10979)
  • ((growth or stimulat$) adj2 (substance$ or factor$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6293)
  • interleukin$.mp. (3631)
  • or/8-10 (14530)
  • 7 and 11 (760)
  • limit 12 to (english and yr=“2003 - 2008”) (404)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69213)
  • RCT.mp. (872)
  • exp Meta Analysis/ (6294)
  • exp “Systematic Review”/ (3554)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22852)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13890)
  • exp PLACEBOS/ (4185)
  • or/14-20 (90540)
  • 13 and 21 (45)
  • *Burns/ (4636)
  • *Daibetic Foot/ (0)
  • *Surgical Wound/ or *Postoperative Complications/ (4754)
  • *Ischemia/ (645)
  • *Venous Ulcer/ (625)
  • or/23-27 (10639)
  • 22 not 28 (39)
Final Search – Press Sores 2008 – Support Surfaces
March 30, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 3 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3494)
  • exp Skin Ulcer/ (12566)
  • exp Wound Healing/ or exp Wound Infection/ (34138)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6933)
  • bedsore$.mp. (97)
  • or/1-5 (45241)
  • Beds/ (1275)
  • exp “Bedding and Linens”/ (1335)
  • (pressure adj2 (relief or reliev$ or reduc$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6386)
  • (sheep?skin$ or sheep skin$ or mattress$ or pillow$ or cushion$ or (support$ adj2 surface) or (support$ adj2 air) or beds or bed or bedding or bolster$ or (foam adj2 wedge$) or (foam adj2 block$) or gelpad$ or gel pad$ or gel-pad$ or gell pad$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (36817)
  • ((pressure or bedsore$ or wound$ or ulcer$ or sore$) adj2 overlay$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (15)
  • (pressure-relief or pressure-reduc$ or pressure-reliev$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (2164)
  • or/7-12 (42829)
  • 6 and 13 (2009)
  • limit 14 to (english language and humans and yr=“2003 - 2008”) (745)
  • limit 15 to (controlled clinical trial or meta analysis or randomized controlled trial) (81)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31521)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59631)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346865)
  • exp Double-Blind Method/ (50479)
  • exp Control Groups/ (535)
  • exp Placebos/ (8762)
  • RCT.mp. (2250)
  • or/16-23 (415760)
  • 15 and 24 (157)
  • limit 25 to (case reports or comment or editorial or letter) (4)
  • 25 not 26 (153)
  • *Burns/ (7238)
  • *Diabetic Foot/ (2585)
  • *Varicose Ulcer/ (1076)
  • *Ischemia/ (8422)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41682)
  • or/28-32 (60558)
  • 27 not 33 (125)
 
Database: EMBASE <1980 to 2008 Week 13>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3890)
  • exp Skin Ulcer/ (17918)
  • exp Chronic Wound/ (231)
  • exp Wound Healing/ or exp Wound Infection/ (50734)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9451)
  • bedsore$.mp. (155)
  • or/1-6 (67244)
  • exp position/ (39965)
  • exp bed/ (2558)
  • exp Protective Equipment/ (11689)
  • (pressure adj2 (relief or reliev$ or reduc$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (12215)
  • (pressure-relief or pressure-reduc$ or pressure-reliev$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (3964)
  • (sheep?skin$ or sheep skin$ or mattress$ or pillow$ or cushion$ or (support$ adj2 surface) or (support$ adj2 air) or beds or bed or bedding or bolster$ or (foam adj2 wedge$) or (foam adj2 block$) or gelpad$ or gel pad$ or gel-pad$ or gell pad$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (57391)
  • ((pressure or bedsore$ or wound$ or ulcer$ or sore$) adj2 overlay$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (11)
  • or/8-14 (118266)
  • 7 and 15 (2582)
  • limit 16 to (human and english language and yr=“2003 - 2008”) (793)
  • Randomized Controlled Trial/ (155932)
  • exp Randomization/ (25259)
  • exp RANDOM SAMPLE/ (1028)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281603)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (57049)
  • Double Blind Procedure/ (68699)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1558)
  • exp PLACEBO/ (111476)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403730)
  • or/18-27 (614387)
  • 17 and 28 (159)
  • limit 29 to (editorial or letter or note) (5)
  • Case Report/ (983732)
  • 29 not (30 or 31) (152)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 3 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5163)
  • exp Skin Ulcer/ (10218)
  • exp Wound Healing/ or exp Wound Infection/ (9511)
  • exp Wounds, Chronic/ (832)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6566)
  • bedsore$.mp. (75)
  • or/1-6 (18318)
  • exp Patient Positioning/ (4200)
  • exp “bedding and linens”/ or exp “beds and mattresses”/ (2265)
  • (pressure adj2 (relief or reliev$ or reduc$)).mp. [mp=title, subject heading word, abstract, instrumentation] (1462)
  • (pressure-relief or pressure-reduc$ or pressure-reliev$).mp. [mp=title, subject heading word, abstract, instrumentation] (791)
  • (sheep?skin$ or sheep skin$ or mattress$ or pillow$ or cushion$ or (support$ adj2 surface) or (support$ adj2 air) or beds or bed or bedding or bolster$ or (foam adj2 wedge$) or (foam adj2 block$) or gelpad$ or gel pad$ or gel-pad$ or gell pad$).mp. [mp=title, subject heading word, abstract, instrumentation] (10655)
  • ((pressure or bedsore$ or wound$ or ulcer$ or sore$) adj2 overlay$).mp. [mp=title, subject heading word, abstract, instrumentation] (16)
  • or/8-13 (15368)
  • 7 and 14 (1908)
  • limit 15 to (english and yr=“2003 - 2008”) (669)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69457)
  • RCT.mp. (874)
  • exp Meta Analysis/ (6315)
  • exp “Systematic Review”/ (3577)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22933)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13946)
  • exp PLACEBOS/ (4198)
  • or/17-23 (90860)
  • 16 and 24 (88)
  • *BURNS/ (4653)
  • *Diabetic Foot/ (1957)
  • *Venous Ulcer/ (628)
  • *Ischemia/ (647)
  • *Surgical Wound/ (145)
  • *Surgical Wound Infection/ (1459)
  • *Postoperative Complications/ (4629)
  • or/26-32 (13984)
  • 25 not 33 (72)
Final Search Pressure Sores 2008 – Electrical Stimulation
Search date: March 24, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Electric Stimulation Therapy/ (13139)
  • (electrostimul$ or electro-stimul$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (833)
  • tens.mp. (2597)
  • (electro-therap$ or electrotherap$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (217)
  • ((electrical or stimulat$ or current or pulse$) adj4 (wound$ or ulcer$ or pressure sore$ or bedsore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (931)
  • or/7-10 (16001)
  • 6 and 12 (184)
  • ((electrical or stimulation) adj4 (wound$ or ulcer$ or pressure sore$ or bedsore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (158)
  • 13 or 14 (315)
  • limit 15 to (english language and humans and yr=“2003 - 2008”) (105)
  • limit 16 to (controlled clinical trial or meta analysis or randomized controlled trial) (11)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/17-24 (414757)
  • 16 and 25 (22)
  • *Burns/ (7235)
  • *Ischemia/ (8409)
  • *Varicose Ulcer/ (1075)
  • *Diabetic Foot/ (2580)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41621)
  • or/27-31 (60476)
  • 26 not 32 (16)
 
Database: EMBASE <1980 to 2008 Week 12>
Search Strategy:
--------------------------------------------------------------------------------
  • exp DECUBITUS/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Wound Healing/ or exp Wound Infection/ (50688)
  • exp Chronic Wound/ (229)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9444)
  • bedsore$.mp. (155)
  • or/1-6 (67188)
  • exp Transcutaneous Nerve Stimulation/ (2628)
  • exp Electrostimulation/ (27469)
  • exp Electrostimulation Therapy/ (75561)
  • (electrostimul$ or electro-stimul$ or tens).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (34248)
  • (electro-therap$ or electrotherap$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (586)
  • or/8-12 (101146)
  • 7 and 13 (535)
  • ((electrical or stimulat$ or current or pulse$) adj4 (wound$ or ulcer$ or pressure sore$ or bedsore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (1666)
  • 14 or 15 (2117)
  • limit 16 to (human and english language and yr=“2003 - 2008”) (559)
  • Randomized Controlled Trial/ (155780)
  • exp Randomization/ (25236)
  • exp RANDOM SAMPLE/ (1022)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281365)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56961)
  • Double Blind Procedure/ (68653)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1545)
  • exp PLACEBO/ (111315)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403354)
  • or/18-27 (613798)
  • 17 and 28 (105)
  • *Burns/ (12430)
  • *Diabetic Foot/ (1981)
  • *Varicosis/ (3637)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10590)
  • or/30-34 (28661)
  • 29 not 35 (91)
  • limit 36 to (editorial or letter or note) (5)
  • Case Report/ (983221) 39 36 not (37 or 38) (85)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5153)
  • exp Wounds, Chronic/ (826)
  • exp Skin Ulcer/ (330)
  • exp Wound Healing/ or exp Wound Infection/ (9484)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6554)
  • bedsore*.mp. (75)
  • or/1-6 (15200)
  • exp Electrotherapy/ (4396)
  • (electrostimul$ or electro-stimul$ or tens).mp. [mp=title, subject heading word, abstract, instrumentation] (504)
  • (electro-therap$ or electrotherap$).mp. [mp=title, subject heading word, abstract, instrumentation] (540)
  • 8 or 9 or 10 (4588)
  • 7 and 11 (185)
  • ((electrical or stimulat$ or current or pulse$) adj4 (wound$ or ulcer$ or pressure sore$ or bedsore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (502)
  • 12 or 13 (547)
  • limit 14 to (english and yr=“2003 - 2008”) (236)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69213)
  • RCT.mp. (872)
  • exp Meta Analysis/ (6294)
  • exp “Systematic Review”/ (3554)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22852)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13890)
  • exp PLACEBOS/ (4185)
  • or/16-22 (90540)
  • 15 and 23 (32)
  • *Burns/ (4636)
  • *Diabetic Foot/ (1954)
  • *Surgical Wound/ or exp Postoperative Complications/ (17091)
  • *Ischemia/ (645)
  • *Venous Ulcer/ (625)
  • or/25-29 (24822)
  • 24 not 30 (18)
Final Search – Pressure Sores - Electromagnetics
Search date: March 24, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Electromagnetics/ (7920)
  • (electromagnet$ or electro-magnet$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (10398)
  • 7 or 8 (10398)
  • 6 and 9 (105)
  • limit 10 to (english language and humans and yr=“2003 - 2008”) (25)
 
Database: EMBASE <1980 to 2008 Week 12>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Wound Healing/ or exp Wound Infection/ (50688)
  • exp Chronic Wound/ (229)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9444)
  • bedsore$.mp. (155)
  • or/1-6 (67188)
  • exp Electromagnetic Field/ (5464)
  • (electromagnet$ or electro-magnet$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (11265)
  • 8 or 9 (11265)
  • 7 and 10 (93)
  • limit 11 to (human and english language and yr=“2003 - 2008”) (20)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5153)
  • exp Skin Ulcer/ (10197)
  • exp Wounds, Chronic/ (826)
  • exp Wound Healing/ or exp Wound Infection/ (9484)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6554)
  • bedsore$.mp. (75)
  • or/1-6 (18277)
  • exp Electromagnetics/ (798)
  • (electro-magnet$ or electromagnet$).mp. [mp=title, subject heading word, abstract, instrumentation] (1089)
  • 8 or 9 (1089)
  • 7 and 10 (46)
  • limit 11 to (english and yr=“2003 - 2008”) (11)
Final Search – Pressure Sores 2008 – Laser Therapy
Search date: March 24, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Laser Therapy/ (20540)
  • (laser$ or lllt or biostimulat$ or bio-stimulat$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (72144)
  • 7 or 8 (72742)
  • 6 and 9 (1637)
  • limit 10 to (english language and humans and yr=“2003 - 2008”) (393)
  • limit 11 to (controlled clinical trial or meta analysis or randomized controlled trial) (65)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/12-19 (414769)
  • 11 and 20 (86)
  • *corneal surgery, laser/ or *keratectomy, subepithelial, laser-assisted/ (153)
  • *Burns/ (7235)
  • *Varicose Ulcer/ (1075)
  • *Diabetic Foot/ (2580)
  • *Ischemia/ (8409)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41621)
  • or/22-27 (60612)
  • 21 not 28 (67)
 
Database: EMBASE <1980 to 2008 Week 12>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Chronic Wound/ (229)
  • exp Wound Healing/ or exp Wound Infection/ (50688)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9444)
  • bedsore$.mp. (155)
  • or/1-6 (67188)
  • exp Low Level Laser Therapy/ (3056)
  • exp Laser/ (36300)
  • (laser$ or lllt or biostim$ or bio-stim$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (102471)
  • or/8-10 (102471)
  • 7 and 11 (3025)
  • limit 12 to (human and english language and yr=“2003 - 2008”) (816)
  • Randomized Controlled Trial/ (155780)
  • exp Randomization/ (25236)
  • exp RANDOM SAMPLE/ (1022)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281365)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56961)
  • Double Blind Procedure/ (68653)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1545)
  • exp PLACEBO/ (111315)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403354)
  • or/14-23 (613798)
  • 13 and 24 (131)
  • *keratomileusis/ or *laser epithelial keratomileusis/ or *laser prostatectomy/ or *photorefractive keratectomy/ (2493)
  • *Burns/ (12430)
  • *Varicosis/ (3637)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10590)
  • *Diabetic Foot/ (1981)
  • or/26-31 (31113)
  • 25 not 32 (110)
 
Database: CINAHL - Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 3 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5163)
  • exp Skin Ulcer/ (10218)
  • exp Wounds, Chronic/ (832)
  • exp Wound Healing/ or exp Wound Infection/ (9511)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6566)
  • bedsore$.mp. (75)
  • exp Lasers/ (1449)
  • (laser$ or lllt or biostimulat$ or bio-stimulat$).mp. [mp=title, subject heading word, abstract, instrumentation] (4819)
  • or/1-6 (18318)
  • 7 or 8 (4907)
  • 9 and 10 (223)
  • limit 11 to (english and yr=“2003 - 2008”) (124)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69457)
  • RCT.mp. (874)
  • exp Meta Analysis/ (6315)
  • exp “Systematic Review”/ (3577)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22933)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13946)
  • exp PLACEBOS/ (4198)
  • or/13-19 (90860)
  • 12 and 20 (26)
Final Search - Pressure Sores 2008 –Ultrasound Therapy
Search date: March 25, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • (bedsore$ or (chronic adj2 wound$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (1425)
  • or/1-5 (45415)
  • exp Ultrasonic Therapy/ (2477)
  • exp ultrasonography/ (88850)
  • ultraso$.mp. (111180)
  • or/7-9 (148047)
  • 6 and 10 (884)
  • limit 11 to (english language and humans and yr=“2003 - 2008”) (286)
  • limit 12 to (controlled clinical trial or meta analysis or randomized controlled trial) (47)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/13-20 (414764)
  • 12 and 21 (59)
  • *Burns/ (7235)
  • *Varicose Ulcer/ (1075)
  • *Diabetic Foot/ (2580)
  • *Ischemia/ (8409)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41621)
  • or/23-27 (60476)
  • 22 not 28 (37)
  • limit 29 to (case reports or comment or editorial or letter) (2)
  • 29 not 30 (35)
 
Database: EMBASE <1980 to 2008 Week 12>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Wound Healing/ (37834)
  • exp Wound Infection/ (14264)
  • exp Chronic Wound/ (229)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (9444)
  • bedsore*.mp. (155)
  • or/1-7 (67188)
  • exp Ultrasound Therapy/ (7582)
  • exp ULTRASOUND/ (36147)
  • ultraso$.mp. (159081)
  • or/9-11 (163633)
  • 8 and 12 (1064)
  • limit 13 to (human and english language and yr=“2003 - 2008”) (430)
  • Randomized Controlled Trial/ (155780)
  • exp Randomization/ (25236)
  • exp RANDOM SAMPLE/ (1022)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281365)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56961)
  • Double Blind Procedure/ (68653)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1545)
  • exp PLACEBO/ (111315)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403354)
  • or/15-24 (613798)
  • 14 and 25 (73)
  • *Burns/ (12430)
  • *Diabetic Foot/ (1981)
  • *Varicosis/ (3637)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10590)
  • or/27-31 (28661)
  • 26 not 32 (70)
  • limit 33 to (editorial or letter or note) (1)
  • Case Report/ (983221)
  • 33 not (34 or 35) (68)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 3 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5163)
  • exp Skin Ulcer/ (10218)
  • exp Wounds, Chronic/ (832)
  • exp Wound Healing/ or exp Wound Infection/ (9511)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6566)
  • bedsore$.mp. (75)
  • or/1-6 (18318)
  • exp Ultrasonic Therapy/ (690)
  • exp Ultrasonography/ (11547)
  • ultraso$.mp. (11565)
  • or/8-10 (16647)
  • 7 and 11 (255)
  • limit 12 to (english and yr=“2003 - 2008”) (139)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69457)
  • RCT.mp. (874)
  • exp Meta Analysis/ (6315)
  • exp “Systematic Review”/ (3577)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22933)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13946)
  • exp PLACEBOS/ (4198)
  • or/14-20 (90860)
  • 13 and 21 (29
Final Search – Pressure Sores 2008 – Nutrition
Search date: March 26, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1996 to March Week 2 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (3492)
  • exp Skin Ulcer/ (12547)
  • bedsore$.mp. (97)
  • exp Wound Healing/ or exp Wound Infection/ (34059)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (6921)
  • or/1-5 (45146)
  • exp Nutrition Therapy/ or exp Nutrition Phenomena/ or exp Diet/ or exp Food/ or exp Nutrition Assessment/ (365004)
  • exp Dietary Supplements/ or exp Minerals/ or exp Antioxidants/ (174383)
  • exp Micronutrients/ (141278)
  • exp Arginine/ (22951)
  • (nutrient$ or nutrition$ or enteral or parenteral or vitamin$ or diet$ or zinc or arginine).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (331182)
  • or/7-11 (654297)
  • 6 and 12 (2974)
  • exp Skin Ulcer/dh [Diet Therapy] (27)
  • exp Pressure Ulcer/dh [Diet Therapy] (16)
  • 13 or 14 or 15 (2977)
  • limit 16 to (english language and humans and yr=“2003 - 2008”) (899)
  • limit 17 to (controlled clinical trial or meta analysis or randomized controlled trial) (105)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (31410)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (59462)
  • exp Random Allocation/ or random$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (346069)
  • exp Double-Blind Method/ (50381)
  • exp Control Groups/ (533)
  • exp Placebos/ (8753)
  • RCT.mp. (2244)
  • or/18-25 (414768)
  • 17 and 26 (179)
  • *Burns/ (7235)
  • *Venous Ulcer/ (1075)
  • *Diabetic Foot/ (2580)
  • *Ischemia/ (8409)
  • *Postoperative Complications/ or *Surgical Wound Infection/ (41621)
  • or/28-32 (60476)
  • 27 not 33 (128)
 
Database: EMBASE <1980 to 2008 Week 12>
Search Strategy:
--------------------------------------------------------------------------------
  • exp DECUBITUS/ (3887)
  • exp Skin Ulcer/ (17909)
  • exp Chronic Wound/ (229)
  • exp Wound Healing/ or exp Wound Infection/ (50688)
  • ((bed or pressure or decubit$ or isch?emic) adj2 (sore$ or ulcer$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (3776)
  • bedsore*.mp. (155)
  • or/1-6 (66870)
  • exp nutrition/ (824071)
  • exp Antioxidant/ (40665)
  • exp Arginine/ (29469)
  • (nutrient$ or nutrition$ or enteral or parenteral or vitamin$ or diet$ or zinc or arginine).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (588013)
  • or/8-11 (1068613)
  • 7 and 12 (5795)
  • limit 13 to (human and english language and yr=“2003 - 2008”) (2120)
  • Randomized Controlled Trial/ (155780)
  • exp Randomization/ (25236)
  • exp RANDOM SAMPLE/ (1022)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (281365)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56961)
  • Double Blind Procedure/ (68653)
  • exp Triple Blind Procedure/ (8)
  • exp Control Group/ (1545)
  • exp PLACEBO/ (111315)
  • (random$ or RCT).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (403354)
  • or/15-24 (613798)
  • 14 and 25 (480)
  • *burns/ (12430)
  • *Diabetic Foot/ (1981)
  • *Varicosis/ (3637)
  • *MICROVASCULAR ISCHEMIA/ (47)
  • *keratomileusis/ or *laser epithelial keratomileusis/ or *laser prostatectomy/ or *photorefractive keratectomy/ (2493)
  • *Postoperative Complication/ or *Surgical Wound/ or *Surgical Infection/ (10590)
  • or/27-32 (31113)
  • 26 not 33 (432)
 
***************************
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to March Week 3 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5163)
  • exp Skin Ulcer/ (10218)
  • exp Wounds, Chronic/ (832)
  • exp Wound Healing/ or exp Wound Infection/ (9511)
  • ((pressure or bed or skin or decubitus) adj2 (ulcer$ or sore$)).mp. [mp=title, subject heading word, abstract, instrumentation] (6566)
  • bedsore$.mp. (75)
  • or/1-6 (18318)
  • exp Diet Therapy/ (7022)
  • exp NUTRITION/ (35506)
  • exp Nutritional Support/ (13136)
  • exp “food and beverages”/ (34182)
  • exp Nutritional Assessment/ (5654)
  • exp Arginine/ (572)
  • (nutrient$ or nutrition$ or enteral or parenteral or vitamin$ or diet$ or zinc or protein$ or arginine).mp. [mp=title, subject heading word, abstract, instrumentation] (92476)
  • or/8-14 (110901)
  • 7 and 15 (1604)
  • exp Pressure Ulcer/dh [Diet Therapy] (52)
  • 16 or 17 (1615)
  • limit 18 to (english and yr=“2003 - 2008”) (754)
  • random$.mp. or exp RANDOM ASSIGNMENT/ or exp RANDOM SAMPLE/ (69457)
  • RCT.mp. (874)
  • exp Meta Analysis/ (6315)
  • exp “Systematic Review”/ (3577)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22933)
  • exp double-blind studies/ or exp single-blind studies/ or exp triple-blind studies/ (13946)
  • exp PLACEBOS/ (4198)
  • or/20-26 (90860)
  • 19 and 27 (95)
  • *burns/ (4653)
  • *Diabetic Foot/ (1957)
  • *Varicose Ulcer/ (628)
  • *ISCHEMIA/ (647)
  • *Surgical Wound Infection/ (1459)
  • *Postoperative Complications/ (4629)
  • *Surgical Wound/ (145)
  • *Keratectomy, Laser/ (3)
  • or/29-36 (13987)
  • 28 not 37 (66)
Final Search – Pressure Ulcers – Patient Care Teams
Search date: March 10, 2008
Databases searched: OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Library, CINAHL, INAHTA/CRD
 
Database: Ovid MEDLINE(R) <1950 to February Week 4 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (7365)
  • ((bed or pressure or decubit$ or isch?emic) adj2 (sore$ or ulcer$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (9219)
  • bedsore$.mp. (275)
  • or/1-3 (9287)
  • exp Patient Care Team/ or exp Combined Modality Therapy/ (179245)
  • exp Delivery of Health Care, Integrated/ or exp “Continuity of Patient Care”/ (14412)
  • exp Interdisciplinary Communication/ (3093)
  • exp Interprofessional Relations/ (37746)
  • (team$ or multi-facet$ or multifacet$ or multifactor$ or multidisciplin$ or multicomponent$ or multi-factor$ or multi-disciplin$ or multi-component$ or interdisciplin$ or inter-disciplin$ or collaborat$ or cooperat$ or co-operat$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (265601)
  • ((wound$ or pressure sore$ or pressure ulcer$ or bedsore$ or bed sore$) adj3 (centre$ or team$ or program$ or clinic or clinics)).mp. [mp=title, original title, abstract, name of substance word, subject heading word] (335)
  • exp Cooperative Behavior/ (12997)
  • or/5-11 (436527)
  • 4 and 12 (690)
  • limit 13 to (english language and humans) (561)
  • exp Technology Assessment, Biomedical/ or exp Evidence-based Medicine/ (34815)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$)).mp. or (published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ab. (68160)
  • 14 and (15 or 16) (32)
  • 14 (561)
  • limit 18 to (case reports or comment or editorial or letter or “review”) (190)
  • 18 not 19 (371)
  • 17 or 20 (384)
 
Database: EMBASE <1980 to 2008 Week 09>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Decubitus/ (3874)
  • ((bed or pressure or decubit$ or isch?emic) adj2 (sore$ or ulcer$)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (3767)
  • exp Decubitus/ (3874)
  • or/1-3 (5279)
  • exp Integrated Health Care System/ (189)
  • exp Interdisciplinary Communication/ (755)
  • exp Cooperation/ or exp Teamwork/ (12687)
  • (team$ or multi-facet$ or multifacet$ or multifactor$ or multidisciplin$ or multicomponent$ or multi-factor$ or multi-disciplin$ or multi-component$ or interdisciplin$ or inter-disciplin$ or collaborat$ or cooperat$ or co-operat$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (176388)
  • ((wound$ or pressure sore$ or pressure ulcer$ or bedsore$ or bed sore$) adj3 (centre$ or team$ or program$ or clinic or clinics)).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] (214)
  • or/5-9 (176649)
  • 4 and 10 (300)
  • limit 11 to (human and english language) (205)
  • exp Biomedical Technology Assessment/ or exp Evidence Based Medicine/ (280024)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or published literature or medline or embase or data synthesis or data extraction or cochrane).ti,ab. (56485)
  • 12 and (13 or 14) (27)
  • 12 (205)
  • limit 16 to (editorial or letter or note or “review”) (70)
  • 16 not 17 (135)
  • 15 or 18 (145)
 
Database: CINAHL – Cumulative Index to Nursing & Allied Health Literature <1982 to February Week 5 2008>
Search Strategy:
--------------------------------------------------------------------------------
  • exp Pressure Ulcer/ (5100)
  • ((bed or pressure or decubit$ or isch?emic) adj2 (sore$ or ulcer$)).mp. [mp=title, subject heading word, abstract, instrumentation] (5799)
  • bedsore$.mp. (74)
  • or/1-3 (5814)
  • exp Multidisciplinary Care Team/ (11467)
  • exp Combined Modality Therapy/ (6430)
  • exp Health Care Delivery, Integrated/ (1644)
  • exp “Continuity of Patient Care”/ (5258)
  • exp Interprofessional Relations/ (8875)
  • exp Cooperative Behavior/ (1027)
  • exp TEAMWORK/ (3186)
  • (team$ or multi-facet$ or multifacet$ or multifactor$ or multidisciplin$ or multicomponent$ or multi-factor$ or multi-disciplin$ or multi-component$ or interdisciplin$ or inter-disciplin$ or collaborat$ or cooperat$ or co-operat$).mp. [mp=title, subject heading word, abstract, instrumentation] (61923)
  • ((wound$ or pressure sore$ or pressure ulcer$ or bedsore$ or bed sore$) adj3 (centre$ or team$ or program$ or clinic or clinics)).mp. [mp=title, subject heading word, abstract, instrumentation] (1178)
  • or/5-13 (79579)
  • 4 and 14 (691)
  • limit 15 to english (663)
  • exp Meta Analysis/ (6147)
  • exp “Systematic Review”/ (3512)
  • (meta analy$ or metaanaly$ or pooled analysis or (systematic$ adj2 review$) or published studies or medline or embase or data synthesis or data extraction or cochrane).mp. (22063)
  • or/17-19 (22063)
  • 16 and 20 (12)
  • 16 (663)
  • limit 22 to (editorial or letter or “review”) (56)
  • 22 not 23 (607)
  • 21 or 24 (607)
Appendix 4: Quality Assessment of Individual Studies
Debridement
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded outcome assessment statedAttrition reportedITT reported
Lee and Ambus, 1975 (24)××[check]×[check]×[check]×
Parish and Collins, 1979 (25)××[check]×[check]×No withdrawalNA
Burgos et al., 2000 (small sample) (26)[check]×[check]×[check][check][check] (High)[check]
Muller et al., 2001 (small sample) (27)×××[check]Only stage×[check]×
Pullen et al, 2002 (28)××[check][check][check][check][check][check]
Alvarez et al., 2002 (small sample) (22)[check]×[check]×[check]×[check][check]
Agren and Stromberg, 1985 (29)××[check] (Inclusion)×[check][check][check][check]
Martin et al, 1996[check]*×[check]×××××
Nasar and Morley, 1982 (30)××[check]××[check][check]×
Ljungberg 1998 (31)×No[check]×[check]×[check]NA
Colin et al., 1996 (32)××××[check]×[check][check]
Thomas et al., 1993 (33)[check]×[check]×[check]×[check]×
Sayag et al., 1996 (34)[check][check][check][check][check][check][check] (High)[check]
Moberg et al., 1983 (35)××[check]×[check]×[check]×
Sherman 2002 (36)× (Non-random)×[check]×[check]×××
*Computer-generated
sealed envelopes
Table of random numbers
§Opaque envelops
Dressings
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded outcome assessment statedAttrition reportedITT reported
Xakellis, 1992 (54)××[check]×[check]×[check]×
Aim 1989, (53)××××[check][check][check]×
Colwell et al., 1993 (55)××[check]× (No description of statistical analysis[check]×[check]×
Matzen, 1998 (56)××[check]×[check]×[check][check]
Hollisaz et al., 2004 (41)[check][check][check][check][check][check][check][check]
Barrois, 1992 (61)××[check]×[check] (Limited)×[check]×
Kim et al., 1996 (59)××××[check]×[check]×
Kaya et al., 2005 (63)××××[check]×None reported×
Mulder et al., 1993 (57)[check]×[check]×[check]×××
Bale, 1997 (66)[check]×[check]×[check]×[check](High)×
Banks, 1994a (67)××[check]×[check]×[check]×
Banks, 1994b (68)[check]×[check]×[check]×[check]×
Thomas, 1997 (44)[check][check][check]×[check]×××
Honde, 1994 (69)[check]×[check]×[check]×[check][check]
Banks, 1996 (77)××[check]×[check]×[check]×
Seeley et al., 1999 (70)[check]×[check]×[check]×[check][check]
Belmin, 2002 (72)××[check][check][check][check][check]
Meaume et al., 2005 (49)[check]×[check]×[check]×[check]
Munter et al., 2006 (50)[check][check][check][check][check]×[check]
Kloth et al., 2002 (73)[check]×[check]×[check]×[check][check]
Price et al., 2000 (75)[check][check][check]×[check] (Stage)[check][check][check]
Thomas et al., 2005 (52)[check][check][check]×[check]×[check]×
Banks, 1997 (43)[check] (Computer)×[check]×[check]×[check]×
Gunes et al., 2007 (51)[check]×[check]×[check]×××
Graumlich, 2003 (11)[check][check][check][check][check][check][check][check]
Subbanna et al., 2007 (40)[check]×[check]×[check]×[check]×
Support Surfaces
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded i outcome assessment statedAttrition reported and reason providedITT reported
Devine et al., 1995 (94)[check]×Exclusion criteria not reported× (Post hoc)[check][check][check][check]
Evans, 2000 (95)[check][check][check]×[check][check][check][check]
Russell, 2000a (96)××[check][check][check][check][check]×
Russell, 2003 (97)[check]*[check][check][check][check][check][check]?
Nixon et al., 2006 (91)[check][check][check][check][check]×[check][check]
Allman et al., 1987 (98)[check][check][check][check][check][check]
Strauss, 1991 (100)[check]*×[check]×Inadequate[check][check] (High deaths and dropout)×
Ferrell and Christenson, 1993 (101)×* (Blocks of 10)[check][check][check][check]×[check]
Mulder et al., 1994 (102)××[check]×No demographic info or baseline ulcer data×× (Overall, not by study groups)×
Day et al., 1993 (103)[check][check][check]×[check]×[check]×
Groen et al., 1999 (104)××[check][check][check]×[check]×
Keogh et al., 2001 (105)[check]*[check]§[check]Stated but not described[check]× (Patient and researcher)[check][check]
Rosenthal et al., 2003 (92)[check]§[check]§[check][check][check]×[check]×
Clark et al., 1999 (106)×[check]§ (Central)[check][check][check]×[check]×
Ochs et al., 2005 (93)[check] (Retrospective)×××[check]×NANA
*Computer-generated
sealed envelopes
Table of random numbers
§Opaque envelops
Adjunctive Physical Therapy
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded outcome assessment statedAttrition reportedITT reported
Electrical
Adunsky et al., 2005 (112)××[check]×[check][check][check][check]
Griffin et al., 1991 (110)×[check][check][check][check]×[check]×
Wood et al., 1993 (111)×[check][check]×[check][check][check]×
Electromagnetic
Comorosan, 1993 (115)
Salsberg, 1995 (116)×[check][check]×[check][check][check]×
Ritz et al., 2002 (117)××[check]×[check][check]××
Burke et al., 1998 (20)×[check][check]××[check][check]×
Laser Therapy
Nussbaum et al., 1994 (123)××××[check][check][check]×
Lucas et al., 2000 (119)××[check]×[check][check][check]×
Lucas et al., 2003 (125)[check]×[check][check][check][check][check][check]
Taly et al., 2004 (121)[check]×[check]×[check][check][check][check]
Schubert et al., 2001 (124)××Minimal×I[check] (Inadequate)×[check]×
Ultrasound Therapy
McDiarmid, 1985 (127)××[check]××[check][check]×
ter Riet et al., 1995) (128)[check]*[check][check][check][check][check][check][check]
Nussbaum et al., 1994 (123)××××[check][check][check]×
Multidisciplinary teams
Vu et al., 2007 (10)Inadequate×[check][check][check]×[check][check]
*By random permuted blocks of 6 prepared in advance using a computer program (Stratified by nursing home, vitamin C supplementation, and grade IV ulcers)
Cluster, not truly randomized
Growth Factors
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded outcome assessment statedAttrition reportedITT reported
Mustoe, 1994 (78)××[check][check][check][check][check]×
Rees, 1999 (79)××[check]×[check]××[check]
Robson, 2000 (80)××[check]×[check][check][check][check]
Landi, 2003 (82)[check]×[check]×[check][check][check]×
Nutrition Therapy
StudyRandomization method statedConcealment of allocation statedInclusion/exclusion criteria statedA priori power calculation reportedBaseline characteristics reportedBlinded outcome assessment statedAttrition reportedITT reported
Chernoff, 1990 (142)××[check]×[check] (Inadequate)×××
Norris et al., 1971 (137)×[check][check]×[check] (Inadequate)×[check]×
Taylor et al., 1974 (139)[check]×××[check] (Inadequate)×××
Ek et al., 1991 (141)××××[check]×[check]×
Benati et al, 2001 (143)××××××××
Desneves et al., 2005 (144)[check]×[check]×[check][check][check][check]
Lee et al., 2006 (24)[check][check][check]×[check][check][check]×
ter Riet, 1995 (140)[check]×[check]×[check][check]××
Appendix 5: Assessment of Quality of Evidence (GRADE)
Quality of Evidence on Debridement
GRADE Quality Assessment*
There was no evidence that debridement using collagenase, dextranomer, or cadexomer iodine significantly improved complete healing compared with placebo.
StudiesDesignQuality of StudiesConsistencyDirectnessOutcome
15 studiesRCTMany limitationsNo limitationsNoneImportant
HighLowLowLowLow
*RCT, randomized controlled trial.
Most were small and did not have a priori power calculation, intention-to-treat, or concealment of allocation. <50% gave method of randomization or reported blinded assessment.
GRADE Quality Assessment*
Papain urea resulted in better debridement than collagenase. Adding streptokinase/streptodornase to hydrogel resulted in faster debridement.
StudiesDesignQuality of StudiesConsistencyDirectnessOutcome
Alvarez, 2002
Martin, 1996
RCTMany limitationsNo limitationsNoneImportant
HighLowLowLowLow
*RCT, randomized controlled trial.
No concealment of allocation, no a priori power calculation, no blinded outcome assessment, no intention-to-treat in one of the studies.
GRADE Quality Assessment*
Calcium alginate resulted in a greater reduction in ulcer size compared with dextranomer. Weighted mean difference in ulcer reduction -2.12 (95% CI, -3.50 to -0.74) (cm2/week)
StudiesDesignQuality of StudyDirectnessModifying FactorsOutcome
Sayag 1996RCTlimitationNo limitationsNoneImportant
HighModerateModerateModerateModerate
*CI, confidence interval; RCT, randomized controlled trial. Consistency is Not applicable with only 1 study
High attrition.
GRADE Quality Assessment*
Maggot debridement resulted in more complete debridement than conventional treatment. Complete debridement at 5 weeks = 80% vs. 52%, P = .021.
StudiesDesignQuality of StudyDirectnessModifying FactorsOutcome
Sherman, 2002Non-randomized Clinical controlled trialSome limitationsNo limitationsNoneImportant
LowVery lowVery lowVery lowVery low
*Consistency is not applicable with only 1 study
Nonrandomized controlled study, no randomization, no concealment, no blinded outcome assessment, and no intention-to-treat.
Quality of Evidence on Dressings
GRADE Quality Assessment*
Ulcer (>Stage II) treated with hydrocolloid dressing for 5-12 weeks had a higher proportion of complete healing compared with those treated with saline gauze dressing (RR, 2.91 [95% CI, 1.52-5.57]).
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Aim, 1989
Colwell, 1993
Matzen, 1999
Hollisaz, 2004
RCTsMany limitationsNoNo limitationRR >2Important
N = 127 vs. 119HighLowLowLowModerateModerate
*CI, confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small sample; no a priori sample calculation; method of randomization not stated; and no blinded outcome assessment.
GRADE Quality Assessment*
Ulcers (Stage ll-lII) treated with hydrogel dressing had a higher proportion of complete healing compared with those treated with hydrocolloid dressing (RR, 1.71 [95% CI, 1.05-2.79])
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Darkovich, 1990
Motta, 1999
RCTsMany limitationsNo limitationNo limitationNoneImportant
N = 67 vs. 72HighLowLowLowLowLow
*CI, confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small samples, no a priori sample calculation, method of randomization not stated, concealment of allocation not stated, attrition not reported, no blinded outcome assessment, and no intention-to-treat analysis.
GRADE Quality Assessment*
Ulcers (Stage II-III) treated with hydropolymer dressing had a higher proportion of complete healing compared with those treated with hydrocolloid dressing (RR, 1.53 [95% CI, 1.05-2.22]).
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Thomas, 1997
Honde, 1994
RCTsMany limitationsNo limitationNo limitationNoneImportant
N = 129 vs 138HighLowLowLowLowLow
*CI, confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small samples, no a priori sample calculation, method of randomization not stated, concealment of allocation not stated, attrition not reported, no blinded outcome assessment, and no intention-to-treat analysis
GRADE Quality Assessment*
There were no significant differences in complete healing of ulcers (Stage lll-IV) treated with normothermic or radiant heat dressing compared with those treated with other advanced dressings.
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Price, 2000
Whitney, 2001
Kloth, 2002
Thomas, 2005
RCTsSome limitationsNo limitationNo limitationNoneImportant
N = 75 vs. 77HighModerateModerateModerateModerateModerate
*RCT, randomized controlled trial.
Quality of Evidence on Growth Factors
GRADE Quality Assessment*
No significant difference in complete healing in pressure ulcers treated with platelet derived growth factor, fibroblast growth factors, or granulocyte macrophage colony-stimulating factor compared with pressure ulcers treated with placebo.
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Mustoe, 1994
Rees, 1999
Payne, 2001
Landi, 2003
RCTsSome limitationsSome limitationsNo limitationNoneImportant
N = 75 vs. 77HighModerateLowLowLowLow
*RCT, randomized controlled trial.
Small sample, method of randomization not stated, and no priori sample size calculation. Uncertainty due to small study size and methodological flaws.
One study showed a different trend in complete healing compared with the other 3 studies.
Quality of Evidence on Electrotherapy
GRADE Quality Assessment*
The adjunct use of electrotherapy significantly improved complete healing compared with sham therapy when a fixed effects model was used but there was significant heterogeneity (RR, 4.48 [95% CI, 1.91-10.51], P = .0006, I2 = 70.1%). The RR became insignificant when a random effects model was used. There was no significant difference when a random effects model was used (RR, 3.08 [95% CI, 0.58-16.41], P= .19, I2 = 70.1%)
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Griffin, 1991
Wood, 1993
Adunsky, 2005
RCTsSome limitationsSome inconsistencyNo limitationNoneImportant
N = 86 vs. 68HighModerateLowLowLowLow
*CI refers to confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small sample size, no method of randomization, no concealment of allocation, and no a priori power calculation.
GRADE Quality Assessment*
The adjunct use of electrotherapy was associated with significantly greater reduction in the size of pressure ulcers.
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Gentzkow, 1991
Griffin, 1991
Wood, 1993
RCTsManylimitationsNoinconsistencyNo limitationNoneImportant
N = 41 vs. 28HighModerateModerateModerateModerateModerate
*RCT refers to randomized controlled trial.
Small sample size, no method of randomization, no concealment of allocation, and no a priori power calculation.
Quality of Evidence on Electromagnetic Therapy
GRADE Quality Assessment*
The adjunct use of electromagnetic therapy did not significantly improve complete healing compared with sham therapy (RR, 3.43 [95% CI, 0.35-33.61], P = .29).
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Comorosan, 1993
Salsberg, 1995
Ritz, 2002
RCTsMany limitationsNo inconsistencyNo limitationNoneImportant
N = 41 vs. 28HighLowLowLowLowLow
*CI refers to confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small samples, no method of randomization, no concealment of allocation, no a priori power calculation, and no intention-to-treat analysis. One study did not provide patient or ulcer characteristics and had imbalanced sample sizes.
Quality of Evidence on Low-Level Laser Therapy
GRADE Quality Assessment*
The adjunct use of low level laser therapy did not significantly improve the complete healing of pressure ulcers compared with standard therapy or sham therapy (RR, 1.17 [95% CI, 0.85-1.63], P = .33).
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Nussbaum, 1994
Lucas, 2000
Lucas, 2003
Taly, 2004
RCTsSome limitationsSome inconsistencyNo limitationNoneImportant
N = 85 vs. 86HighmoderateLowLowLowLow
*CI refers to confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small sample, no concealment of allocation, and no a priori power calculation.
One study had a different trend.
Quality of Evidence on Ultrasound Therapy
GRADE Quality Assessment*
The adjunct use of ultrasound therapy did not significantly improve complete healing of pressure ulcers compared with sham therapy (RR, 0.97 [95% CI, 0.65-1.45], P = .89)
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
McDiarmid, 1985
ter Riet, 1995
RCTsSome limitationsNo inconsistencyNo limitationNoneImportant
N = 66 vs. 62HighModerateModerateModerateModerateModerate
*CI refers to confidence interval; RCT, randomized controlled trial; RR, relative risk.
Small samples. One study had no description of method of randomization, no concealment of allocation, and no a priori sample calculation.
GRADE Quality Assessment*
The adjunct use of ultrasound therapy in conjunction with ultraviolet therapy did not significantly improve complete healing compared with standard therapy or low-level laser therapy.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Nussbaum, 1994RCTMany limitationsNo limitationNoneImportant
N = 6 vs. 6HighLowLowLowLow
*RCT refers to randomized controlled trial; Consistency is not applicable with 1 study
No method of randomization or concealment, no inclusion/exclusion criteria, no a priori power calculation, and no intention-to-treat.
Quality of Evidence on Negative Pressure Therapy
GRADE Quality Assessment*
The adjunct use of negative pressure therapy did not significantly improve complete healing compared with standard therapy including a debridement gel.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Ford, 2002RCTMany limitationsNo limitationNoneImportant
N =20 vs. 15HighLowLowLowLow
*RCT refers to randomized controlled trial; Consistency is not applicable with 1 study
Very small sample, no method of randomization, no concealment of allocation, no inclusion/exclusion criteria, and no apriori power calculation.
Quality of Evidence on Nutrition Support Therapy
GRADE Quality Assessment*
Supplementation with 15 grams of hydrolyzed protein 3 times daily did not improve complete healing of pressure ulcers but was associated with a 2-fold improvement in PUSH score compared with placebo.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Lee, 2006RCTsSome limitations†No limitationNoneImportant
N = 89HighModerateLowLowLow
*RCT refers to randomized controlled trial; PUSH, pressure ulcer scale for healing; Consistency is not applicable with 1 study
GRADE Quality Assessment*
Supplementation with 500 mg ascorbic acid twice daily for 1 month was associated with significantly greater reduction in the size of ulcers compared with placebo.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Taylor, 1974RCTMany limitationsNo limitationNoneImportant
N = 20HighLowLowLowLow
*RCT refers to randomized controlled trial; Consistency is not applicable with 1 study
No concealment of allocation, no inclusion/exclusion criteria, no a priori power calculation, inadequate baseline information, no report on attrition, and no intention-to-treat.
GRADE Quality Assessment*
Supplementation with 200 mg Zinc (as zinc sulphate) did not significantly improve the healing of pressure ulcers compared with placebo.
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Norris 1971
Brewer 1967
RCTSome limitationsSome inconsistencyNo limitationNoneImportant
N = 31HighModerateLowLowLowLow
*RCT refers to randomized controlled trial.
No method of randomization, a priori power calculation, inadequate baseline information, no blinded assessment, no intention-to-treat.
GRADE Quality Assessment*
Supplementation with 500 mg ascorbic acid twice daily for 12 weeks did not significantly improve the absolute or relative reduction in the surface area or volume of ulcers compared with supplementation with 10 mg ascorbic acid twice daily.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
ter Riet, 1995RCTSome limitationsNo limitationNoneImportant
N = 88HighModerateLowLowLow
*RCT refers to randomized controlled trial; consistency not applicable with 1 study
GRADE Quality Assessment*
A very high protein feeding (25% of energy as protein) resulted in a greater reduction in the area of ulcers in institutionalized tube-fed patients compared with a lower protein feeding (16% of the energy as protein).
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Chernoff, 1990RCTMany limitationsNo limitationNoneImportant
N = 12HighLowLowLowLow
*RCT, randomized controlled trial; Consistency is not applicable with only 1 study
No method of randomization, concealment of allocation, a priori power calculation, inadequate baseline information, no blinded outcome assessment, no report on attrition, and no intention-to-treat.
GRADE Quality Assessment*
A multinutrient supplemental feeding containing 1600 kJ, 16 g protein, and vitamins and minerals did not significantly improve the complete healing of pressure ulcers compared with standard diet alone.
StudiesDesignQuality of StudiesDirectnessModifying FactorsOutcome
Ek, 1991RCTsMany limitationsNo limitationNoneImportant
N = 150HighLowLowLowLow
*RCT, randomized controlled trial; Consistency is not applicable with only 1 study.
No method of randomization, concealment of allocation, no inclusion/exclusion criteria, no a priori power calculation, no blinded outcome assessment, and no intention-to-treat.
GRADE Quality Assessment*
A high protein high energy multinutrient supplemental feeding with added arginine, zinc, and vitamins was associated with a greater decrease in the size of the ulcer and improvement in ulcer scores compared with a similar feeding without added arginine, zinc and vitamin C or compared with a standard diet alone.
StudiesDesignQuality of StudiesConsistencyDirectnessModifying FactorsOutcome
Benati, 2001
Desneves, 2005
RCTsMany limitationsNo inconsistencyNo limitationNoneImportant
N = 31HighLowLowLowLowLow
*RCT, randomized controlled trial.
One study had better quality than the other did. No method of randomization in one study, no blinded outcome assessment in one study, and no intention-to-treat in one study. No method of concealment of allocation no a priori power calculation in either study,.
Notes
Suggested Citation
This report should be cited as follows:
Medical Advisory Secretariat. Management of chronic pressure ulcers: an evidence-based analysis. Ontario Health Technology Assessment Series 2009;9(3).
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Abbreviations
AHAmorphous hydrogel
AHRQAgency for Healthcare Research and Quality
AlAluminum
APAlternating pressure
AsArsenide
BFGFBasic fibroblast growth factor
BIDTwice daily
CCollagenase
CIConfidence interval
DDextranomer paste
DDCTDecubitus direct current treatment
DIMEDebridement, infection control, moist wound environment, and edge effect
DNAaseDeoxyribonuclease
FDAFood and Drug Administration
FGFFibroblast growth factor
GAGallium
GM-CSFGranulo macrophage-colony stimulating factor
GRADEGrading of Recommendation Assessment, Development, and Evaluation
HeHelium
HINFHigh Intensity Fund
HRHazard ratio
kJKilojoule
LALLow-air-loss
LLLLow-level laser
LOSLength of stay
LPLow pressure
LTCLong-term care
MCSFMacrophage-colony stimulating factor
MDMedical doctor
UgMicrogram
mgMilligram
mLMillilitre
MVPMoisture vapour permeable
NANot applicable
NCNTNoncontact normothermic therapy
NENeon
NGFNerve growth factor
NPUAPNational Pressure Ulcer Advisory Panel
NPWTNegative pressure wound therapy
NSNot statistically significant
OROdds ratio
PBOPlacebo
PDGFPlatelet-derived growth factor
PMNPolymorphonuclear neutrophils
PSSTPressure Sore Status Tool
PTPhysical therapist
PUSHPressure Ulcer Scale for Healing
RCNRoyal College of Nurses
RCTRandomized controlled trial
RDRegistered dietician
rhPDGFRecombinant human platelet-derived growth factor
RNRegistered nurse
RRRelative risk
RRRelative risk
SATASpacial and temporal averaged
SCISpinal cord injury
SDStandard deviation
TGFTransforming growth factor
TxTreatment
UCVUltraviolet C
us/uvcUltrasound/ultraviolet C
VAVeterans Administration
VACVacuum-assisted closure
WMDWeighted mean difference

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