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1.  Negative Pressure Wound Therapy 
Executive Summary
Objective
This review was conducted to assess the effectiveness of negative pressure wound therapy.
Clinical Need: Target Population and Condition
Many wounds are difficult to heal, despite medical and nursing care. They may result from complications of an underlying disease, like diabetes; or from surgery, constant pressure, trauma, or burns. Chronic wounds are more often found in elderly people and in those with immunologic or chronic diseases. Chronic wounds may lead to impaired quality of life and functioning, to amputation, or even to death.
The prevalence of chronic ulcers is difficult to ascertain. It varies by condition and complications due to the condition that caused the ulcer. There are, however, some data on condition-specific prevalence rates; for example, of patients with diabetes, 15% are thought to have foot ulcers at some time during their lives. The approximate community care cost of treating leg ulcers in Canada, without reference to cause, has been estimated at upward of $100 million per year.
Surgically created wounds can also become chronic, especially if they become infected. For example, the reported incidence of sternal wound infections after median sternotomy is 1% to 5%. Abdominal surgery also creates large open wounds. Because it is sometimes necessary to leave these wounds open and allow them to heal on their own (secondary intention), some may become infected and be difficult to heal.
Yet, little is known about the wound healing process, and this makes treating wounds challenging. Many types of interventions are used to treat wounds.
Current best practice for the treatment of ulcers and other chronic wounds includes debridement (the removal of dead or contaminated tissue), which can be surgical, mechanical, or chemical; bacterial balance; and moisture balance. Treating the cause, ensuring good nutrition, and preventing primary infection also help wounds to heal. Saline or wet-to-moist dressings are reported as traditional or conventional therapy in the literature, although they typically are not the first line of treatment in Ontario. Modern moist interactive dressings are foams, calcium alginates, hydrogels, hydrocolloids, and films. Topical antibacterial agents—antiseptics, topical antibiotics, and newer antimicrobial dressings—are used to treat infection.
The Technology Being Reviewed
Negative pressure wound therapy is not a new concept in wound therapy. It is also called subatmospheric pressure therapy, vacuum sealing, vacuum pack therapy, and sealing aspirative therapy.
The aim of the procedure is to use negative pressure to create suction, which drains the wound of exudate (i.e., fluid, cells, and cellular waste that has escaped from blood vessels and seeped into tissue) and influences the shape and growth of the surface tissues in a way that helps healing. During the procedure, a piece of foam is placed over the wound, and a drain tube is placed over the foam. A large piece of transparent tape is placed over the whole area, including the healthy tissue, to secure the foam and drain the wound. The tube is connected to a vacuum source, and fluid is drawn from the wound through the foam into a disposable canister. Thus, the entire wound area is subjected to negative pressure. The device can be programmed to provide varying degrees of pressure either continuously or intermittently. It has an alarm to alert the provider or patient if the pressure seal breaks or the canister is full.
Negative pressure wound therapy may be used for patients with chronic and acute wounds; subacute wounds (dehisced incisions); chronic, diabetic wounds or pressure ulcers; meshed grafts (before and after); or flaps. It should not be used for patients with fistulae to organs/body cavities, necrotic tissue that has not been debrided, untreated osteomyelitis, wound malignancy, wounds that require hemostasis, or for patients who are taking anticoagulants.
Review Strategy
The inclusion criteria were as follows:
Randomized controlled trial (RCT) with a sample size of 20 or more
Human study
Published in English
Summary of Findings
Seven international health technology assessments on NPWT were identified. Included in this list of health technology assessments is the original health technology review on NPWT by the Medical Advisory Secretariat from 2004. The Medical Advisory Secretariat found that the health technology assessments consistently reported that NPWT may be useful for healing various types of wounds, but that its effectiveness could not be empirically quantified because the studies were poorly done, the patient populations and outcome measures could not be compared, and the sample sizes were small.
Six RCTs were identified that compared NPWT to standard care. Five of the 6 studies were of low or very low quality according to Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. The low and very low quality RCTs were flawed owing to small sample sizes, inconsistent reporting of results, and patients lost to follow-up. The highest quality study, which forms the basis of this health technology policy assessment, found that:
There was not a statistically significant difference (≥ 20%) between NPWT and standard care in the rate of complete wound closure in patients who had complete wound closure but did not undergo surgical wound closure (P = .15).
The authors of this study did not report the length of time to complete wound closure between NPWT and standard care in patients who had complete wound closure but who did not undergo surgical wound closure
There was no statistically significant difference (≥ 20%) in the rate of secondary amputations between the patients that received NPWT and those that had standard care (P = .06)
There may be an increased risk of wound infection in patients that receive NPWT compared with those that receive standard care.
Conclusion
Based on the evidence to date, the clinical effectiveness of NPWT to heal wounds is unclear. Furthermore, saline dressings are not standard practice in Ontario, thereby rendering the literature base irrelevant in an Ontario context. Nonetheless, despite the lack of methodologically sound studies, NPWT has diffused across Ontario.
Discussions with Ontario clinical experts have highlighted some deficiencies in the current approach to wound management, especially in the community. Because NPWT is readily available, easy to administer, and may save costs, compared with multiple daily conventional dressing changes, it may be used inappropriately. The discussion group highlighted the need to put in place a coordinated, multidisciplinary strategy for wound care in Ontario to ensure the best, continuous care of patients.
PMCID: PMC3379164  PMID: 23074484
2.  Genomic and Proteomic Evaluation of Tissue Quality of Porcine Wounds Treated With Negative Pressure Wound Therapy in Continuous, Noncontinuous, and Instillation Modes 
Eplasty  2014;14:e43.
Objective: Negative pressure wound therapy with instillation (NPWTi-d) combines NPWT with automated delivery and removal of topical wound treatment solutions. This porcine study compared genomic and proteomic responses of wounds treated with NPWTi-d with saline to wounds treated with NPWT in continuous and noncontinuous modes. Methods: Full-thickness porcine dorsal excisional wounds were treated with continuous NPWT, intermittent NPWT, dynamic NPWT, or NPWTi-d with saline (n = 10 wounds per group). On day 7, animals were euthanized and tissues collected. Real-time quantitative polymerase chain reaction arrays profiled expression of 84 genes including extracellular matrix remodeling factors, inflammatory cytokines and chemokines, and growth factors and major signaling molecules. Concentrations of proteins associated with angiogenesis, extracellular matrix components, and cellular energetics were analyzed via enzyme-linked immunosorbent assays. Results: Gene expression profiles for NPWTi-d with saline and continuous NPWT were similar. There were 5 upregulated and 18 downregulated genes overexpressed in NPWTi-d compared to NPWT wounds. Protein content was comparable in all treatment groups and similar to unwounded tissue. Conclusions: Previous preclinical studies have reported an increased rate of granulation tissue formation with NPWTi-d with saline compared to NPWT in continuous and noncontinuous modes. This evaluation of gene and protein expression suggests that the granulation tissue in these wounds has a similar quality. This first look at the differences in gene expression, particularly in genes related to remodeling, cell adhesion, inflammation, and growth factors, could help to clarify the observed differences in granulation rates.
PMCID: PMC4258932  PMID: 25525482
genomics; proteomics; negative-pressure wound therapy; hypertonic saline solution; instillation
3.  Comparison of the Effects of Different Negative Pressure Wound Therapy Modes—Continuous, Noncontinuous, and With Instillation—on Porcine Excisional Wounds 
Eplasty  2013;13:e51.
Objective: Negative pressure wound therapy (NPWT) can be delivered in continuous or noncontinuous modes, while NPWT with instillation (NPWTi) couples NPWT with automated delivery and removal of topical wound treatment solutions and suspensions. This porcine study compared granulation response of NPWTi (instillation foam dressing with saline) to NPWT (standard foam dressing) in continuous and noncontinuous modes. Methods: Full-thickness dorsal excisional wounds in pigs were treated with continuous NPWT, intermittent NPWT, dynamic (controlled variable) NPWT, and NPWTi with saline (n = 10 per group). Wound dimensions were determined from 3D images collected on days 0, 2, 5, and 7. On day 7, animals were euthanized and specimens were harvested for histopathological review. Results: Average granulation thickness was not statistically different among continuous (3.29 ± 0.33 mm), intermittent (3.03 ± 0.47 mm), and dynamic (3.40 ± 0.34 mm) NPWT wounds at day 7. Average granulation thickness of NPWTi wounds (4.75 ± 0.54 mm), however, was statistically greater (P < .05) by 44%, 57%, and 40%, respectively, than that of wounds treated with continuous, intermittent, and dynamic NPWT. Analysis of 3D images revealed a greater reduction in wound area and perimeter in NPWTi wounds compared to all NPWT wounds (P < .05). In addition, the average wound fill rate for NPWTi wounds was faster than that for continuous (40%; P < .05), intermittent (25%; P > .05), and dynamic (65%; P < .05) NPWT wounds. Conclusions: Although not confirmed in humans, these porcine data suggest that NPWTi with saline may stimulate a faster rate of wound granulation than NPWT in continuous and noncontinuous modes.
PMCID: PMC3791820  PMID: 24106564
dynamic NPWT; negative pressure wound therapy with instillation; preclinical model; variable NPWT; wound cleansing
4.  Use of Negative Pressure Wound Therapy With Automated, Volumetric Instillation for the Treatment of Extremity and Trunk Wounds: Clinical Outcomes and Potential Cost-Effectiveness 
Eplasty  2014;14:e41.
Objective: A growing body of literature supports use of negative pressure wound therapy (NPWT) with instillation and dwell time (NPWTi-d) with positive clinical outcomes and potential cost savings. A retrospective analysis was performed to compare clinical outcomes of wounds treated with NPWTi-d versus NPWT and to estimate cost-differences between treatments based on clinical outcomes. Methods: Data were extracted from records of patients with extremity or trunk wounds treated with NPWT (n = 34) or NPWTi-d using saline or polyhexanide (n = 48). On the basis of outcomes data, a hypothetical economic model using cost assumptions was created to calculate cost savings for NPWTi-d (related to) number of debridements and length of therapy. Operating room debridement cost was $3393 according to Granick et al. Daily therapy cost for each modality was $194.80 (NPWTi-d) and $106.08 (NPWT) based on internal company information. Results: Results showed significant differences (P < 0.0001) between NPWTi-d and NPWT patients, respectively, for the following: mean operating room debridements (2.0 vs 4.4), mean hospital stay (8.1 vs 27.4 days), mean length of therapy (4.1 vs 20.9 days), and mean time to wound closure (4.1 vs 20.9 days). Hypothetical economic model showed potential average reduction of $8143 for operating room debridements between NPWTi-d ($6786) and NPWT ($14,929) patients. There was a $1418 difference in average therapy costs between groups ($799/NPWTi-d vs $2217/NPWT). Conclusions: In this study, NPWTi-d appeared to assist in wound cleansing and exudate removal, which may have allowed for earlier wound closure compared to NPWT. Hypothetical economic model findings illustrate potential cost-effectiveness of NPWTi-d compared to NPWT.
PMCID: PMC4226049  PMID: 25525480
cost-effectiveness; dwell time; health economics; instillation therapy; negative pressure wound therapy with instillation
5.  Negative Pressure Wound Therapy of Chronically Infected Wounds Using 1% Acetic Acid Irrigation 
Archives of Plastic Surgery  2015;42(1):59-67.
Background
Negative-pressure wound therapy (NPWT) induces angiogenesis and collagen synthesis to promote tissue healing. Although acetic acid soaks normalize alkali wound conditions to raise tissue oxygen saturation and deconstruct the biofilms of chronic wounds, frequent dressing changes are required.
Methods
Combined use of NPWT and acetic acid irrigation was assessed in the treatment of chronic wounds, instilling acetic acid solution (1%) beneath polyurethane membranes twice daily for three weeks under continuous pressure (125 mm Hg). Clinical photographs, pH levels, cultures, and debrided fragments of wounds were obtained pre- and posttreatment. Tissue immunostaining (CD31, Ki-67, and CD45) and reverse transcription-polymerase chain reaction (vascular endothelial growth factor [VEGF], vascular endothelial growth factor receptor [VEGFR]; procollagen; hypoxia-inducible factor 1 alpha [HIF-1-alpha]; matrix metalloproteinase [MMP]-1,-3,-9; and tissue inhibitor of metalloproteinase [TIMP]) were also performed.
Results
Wound sizes tended to diminish with the combined therapy, accompanied by drops in wound pH (weakly acidic or neutral) and less evidence of infection. CD31 and Ki-67 immunostaining increased (P<0.05) post-treatment, as did the levels of VEGFR, procollagen, and MMP-1 (P<0.05), whereas the VEGF, HIF-1-alpha, and MMP-9/TIMP levels declined (P<0.05).
Conclusions
By combining acetic acid irrigation with negative-pressure dressings, both the pH and the size of chronic wounds can be reduced and infections be controlled. This approach may enhance angiogenesis and collagen synthesis in wounds, restoring the extracellular matrix.
doi:10.5999/aps.2015.42.1.59
PMCID: PMC4297808  PMID: 25606491
Acetic acid; Biofilm; Negative pressure wound therapy
6.  Wound Chemotherapy by the Use of Negative Pressure Wound Therapy and Infusion 
Eplasty  2010;10:e9.
Introduction: Although the use of negative pressure wound therapy (NPWT) is broadly efficacious, it may foster some potentially adverse complications. This is particularly true in patients with diabetes who have a wound colonized with aerobic organisms. Traditional antiseptics have been proven useful to combat such bacteria but require removal of some NPWT devices to be effective. Methods: In this article, we describe a method of “wound chemotherapy” by combining NPWT and a continuous infusion of Dakins' 0.5% solution either as a standardized technique in one device (ITI Sved) or as a modification of standard technique in another (KCI VAC) NPWT device. The twin goals of both techniques are to effectively reduce bacterial burden and to promote progressive wound healing. Results: We present several representative case examples of our provisional experience with continuous streaming therapy through 2 foam-based negative pressure devices. Discussion: Wound chemotherapy was successfully applied to patients with diabetes, without adverse reactions, complications, or recolonization during the course of treatment. We believe this to be a promising method to derive the benefits of NPWT without the frequent adverse sequela of wound colonization.
PMCID: PMC2806786  PMID: 20090841
7.  Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial 
Trials  2014;15(1):334.
Background
In August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment.
Methods/Design
The DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer’s instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs.
Discussion
The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems.
Trial registration
Clinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).
German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).
doi:10.1186/1745-6215-15-334
PMCID: PMC4156638  PMID: 25158846
Diabetic foot wound; Amputation wound; Chronic wound; Foot ulcer; Diabetic foot; Foot diseases; Diabetes complications; Diabetes mellitus; Negative pressure wound therapy
8.  SNaP® Wound Care System: Ultraportable Mechanically Powered Negative Pressure Wound Therapy 
Advances in Wound Care  2012;1(1):41-43.
Problem
Negative pressure wound therapy (NPWT) is a well-accepted modality for treatment of difficult wounds, but has traditionally required a bulky electrically powered pump that was difficult to procure and use for both caregivers and patients. Often times, treatment of refractory smaller-sized wounds was impractical even though they may benefit from NPWT.
Solution
Spiracur (Sunnyvale, CA) has developed a simple, easy-to-use, single-use, off-the-shelf, mechanically powered NPWT device that weighs <3 ounces. This device allows for the practical treatment of smaller-sized wounds with NPWT designed specifically for the ambulatory patient being treated at home.
New Technology
The Smart Negative Pressure (SNaP®) Wound Care System is a novel light-weight NPWT device that does not require an electrically powered pump. Instead, the SNaP system utilizes specialized springs to generate a preset (−75, −100, and −125 mmHg) continuous subatmospheric pressure level to the wound bed. This technology has demonstrated similar efficacy and increased usability for both clinicians and patients when compared with electrically powered NPWT devices.
Indications for Use
Chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), and surgically closed incisions and flaps.
Cautions
Wounds with excess necrotic tissue, active infection, fistulas, exposed vital structures, untreated osteomyelitis, and that are highly exudative. The SNaP system was not designed for wounds that exceed the size of the dressing in surface area or have exudate levels greater than capacity of the cartridge.
doi:10.1089/wound.2011.0281
PMCID: PMC3839001  PMID: 24527277
9.  Use of an Acellular Regenerative Tissue Matrix Over Chronic Wounds 
Eplasty  2013;13:e61.
Objectives: Bioengineered skin grafts, including acellular dermal matrices, may be effective in treating lower extremity and trunk wounds that are not responsive to traditional wound management. Acellular dermal wound matrix is derived from human acellular dermal wound matrix (HADWM) tissue and provides a scaffold that supports cellular repopulation and revascularization. The major structural components of the dermis are retained during processing, and a single application has been shown to help achieve wound closure. Methods: This patient case series examined the use of HADWM on lower extremity and trunk wounds in 11 patients (6 male and 5 female) with a mean age of 55 years (range: 31–83 years). Wounds were debrided 1 to 2 times, followed by placement of HADWM (range: 4–330 cm2) on wounds that varied from the dorsal surface of the foot, lower abdomen, and lower extremity to the Achilles flap. A nonadherent layer in conjunction with bacitracin was placed over HADWM. Negative pressure wound therapy (NPWT) was placed over the HADWM and initiated continuously at −125 mm Hg for 1 to 2 weeks. After the application of NPWT, HADWM was covered with various gauze dressings using mineral oil. Results: All patients completed their treatment successfully, and follow-up ranged from 1 week to 6 months. One patient experienced an infection, which resulted in partial graft loss that required replacement with HADWM and NPWT. No additional complications occurred in the other patients. Conclusions: This patient case series demonstrated successful use of HADWM and NPWT, which further supports published studies documenting HADWM success in chronic wounds.
PMCID: PMC3840787  PMID: 24324850
chronic wound; human acellular dermal matrix; lower extremity; matrix; NPWT
10.  Extended negative pressure wound therapy-assisted dermatotraction for the closure of large open fasciotomy wounds in necrotizing fasciitis patients 
Background
Necrotizing fasciitis (NF) is a rapid progressive infection of the subcutaneous tissue or fascia and may result in large open wounds. The surgical options to cover these wounds are often limited by the patient condition and result in suboptimal functional and cosmetic wound coverage. Dermatotraction can restore the function and appearance of the fasciotomy wound and is less invasive in patients with comorbidities. However, dermatotraction for scarred, stiff NF fasciotomy wounds is often ineffective, resulting in skin necrosis. The authors use extended negative pressure wound therapy (NPWT) as an assist in dermatotraction to close open NF fasciotomy wounds. The authors present the clinical results, followed by a discussion of the clinical basis of extended NPWT-assisted dermatotraction.
Methods
A retrospective case series of eight patients with NF who underwent open fasciotomy was approved for the study. After serial wound preparation, dermatotraction was applied in a shoelace manner using elastic vessel loops. Next, the extended NPWT was applied over the wound. The sponge was three times wider than the wound width, and the transparent covering drape almost encircled the anatomical wound area. The negative pressure of the NPWT was set at a continuous 100 mmHg by suction barometer. The clinical outcome was assessed based on wound area reduction after treatment and by the achievement of direct wound closure.
Results
After the first set of extended NPWT-assisted dermatotraction procedures, the mean wound area was significantly decreased (658.12 cm2 to 29.37 cm2; p = 0.002), as five out of eight patients achieved direct wound closure. One patient with a chest wall defect underwent latissimus dorsi musculocutaneous flap coverage, with primary closure of the donor site. Two Fournier’s gangrene patients underwent multiple sets of treatment and finally achieved secondary wound closure with skin grafts. The patients were followed up for 18.3 months on average and showed satisfactory results without wound recurrence.
Conclusions
Extended NPWT-assisted dermatotraction advances scarred, stiff fasciotomy wound margins synergistically in NF and allows direct closure of the wound without complications. This method can be another good treatment option for the NF patient with large open wounds whose general condition is unsuitable for extensive reconstructive surgery.
doi:10.1186/1749-7922-9-29
PMCID: PMC3996171  PMID: 24731449
Necrotizing fasciitis; Negative pressure wound therapy; Dermatotraction; Fournier’s gangrene; Fasciotomy
11.  Negative-pressure wound therapy induces endothelial progenitor cell mobilization in diabetic patients with foot infection or skin defects 
Non healing chronic wounds are difficult to treat in patients with diabetes and can result in severe medical problems for these patients and for society. Negative-pressure wound therapy (NPWT) has been adopted to treat intractable chronic wounds and has been reported to be effective. However, the mechanisms underlying the effects of this treatment have not been elucidated. To assess the vasculogenic effect of NPWT, we evaluated the systemic mobilization of endothelial progenitor cells (EPCs) during NPWT. Twenty-two of 29 consecutive patients who presented at the clinic of Seoul National Universty Hospital between December 2009 and November 2010 who underwent NPWT for diabetic foot infections or skin ulcers were included in this study. Peripheral blood samples were taken before NPWT (pre-NPWT) and 7–14 days after the initiation of NPWT (during-NPWT). Fluorescence-activated cell sorting (FACS) analysis showed that the number of cells in EPC-enriched fractions increased after NPWT, and the numbers of EPC colony forming units (CFUs) significantly increased during NPWT. We believe that NPWT is useful for treating patients with diabetic foot infections and skin ulcers, especially when these conditions are accompanied by peripheral arterial insufficiency. The systemic mobilization of EPCs during NPWT may be a mechanism for healing intractable wounds in diabetic patients with foot infections or skin defects via the formation of increased granulation tissue with numerous small blood vessels.
doi:10.1038/emm.2013.129
PMCID: PMC3849576  PMID: 24232261
diabetic foot; endothelial progenitor cell; negative-pressure wound therapy
12.  Wound contraction and macro-deformation during negative pressure therapy of sternotomy wounds 
Background
Negative pressure wound therapy (NPWT) is believed to initiate granulation tissue formation via macro-deformation of the wound edge. However, only few studies have been performed to evaluate this hypothesis. The present study was performed to investigate the effects of NPWT on wound contraction and wound edge tissue deformation.
Methods
Six pigs underwent median sternotomy followed by magnetic resonance imaging in the transverse plane through the thorax and sternotomy wound during NPWT at 0, -75, -125 and -175 mmHg. The lateral width of the wound and anterior-posterior thickness of the wound edge was measured in the images.
Results
The sternotomy wound decreased in size following NPWT. The lateral width of the wound, at the level of the sternum bone, decreased from 39 ± 7 mm to 30 ± 6 mm at -125 mmHg (p = 0.0027). The greatest decrease in wound width occurred when switching from 0 to -75 mmHg. The level of negative pressure did not affect wound contraction (sternum bone: 32 ± 6 mm at -75 mmHg and 29 ± 6 mm at -175 mmHg, p = 0.0897). The decrease in lateral wound width during NPWT was greater in subcutaneous tissue (14 ± 2 mm) than in sternum bone (9 ± 2 mm), resulting in a ratio of 1.7 ± 0.3 (p = 0.0423), suggesting macro-deformation of the tissue. The anterior-posterior thicknesses of the soft tissue, at 0.5 and 2.5 cm laterally from the wound edge, were not affected by negative pressure.
Conclusions
NPWT contracts the wound and causes macro-deformation of the wound edge tissue. This shearing force in the tissue and at the wound-foam interface may be one of the mechanisms by which negative pressure delivery promotes granulation tissue formation and wound healing.
doi:10.1186/1749-8090-5-75
PMCID: PMC2958889  PMID: 20920290
13.  Sternum wound contraction and distension during negative pressure wound therapy when using a rigid disc to prevent heart and lung rupture 
Background
There are increasing reports of deaths and serious complications associated with the use of negative pressure wound therapy (NPWT), of which right ventricular heart rupture is the most devastating. The use of a rigid barrier has been suggested to offer protection against this lethal complication by preventing the heart from being drawn up against the sharp edges of the sternum. The aim of the present study was to determine whether a rigid barrier can be safely inserted over the heart with regard to the sternum wound edge movement.
Methods
Sternotomy wounds were created in eight pigs. The wounds were treated with NPWT at -40, -70, -120 and -170 mmHg in the presence and absence of a rigid barrier between the heart and the edges of the sternum. Wound contraction upon NPWT application, and wound distension under mechanical traction to draw apart the edges of the sternotomy were evaluated.
Results
Wound contraction resulting from NPWT was similar with and without the rigid barrier. When mechanical traction was applied to a NPWT treated sternum wound, the sternal edges were pulled apart. Wound distension upon traction was similar in the presence and absence of a the rigid barrier during NPWT.
Conclusions
A rigid barrier can safely be inserted between the heart and the edges of the sternum to protect the heart and lungs from rupture during NPWT. The sternum wound edge is stabilized equally well with as without the rigid barrier during NPWT.
doi:10.1186/1749-8090-6-42
PMCID: PMC3073896  PMID: 21450095
14.  Effects of Negative Pressure Wound Therapy on Mesenchymal Stem Cells Proliferation and Osteogenic Differentiation in a Fibrin Matrix 
PLoS ONE  2014;9(9):e107339.
Vacuum-assisted closure (VAC) negative pressure wound therapy (NPWT) has been proven to be an effective therapeutic method for the treatment of recalcitrant wounds. However, its role in bone healing remains to be unclear. Here, we investigated the effects of NPWT on rat periosteum-derived mesenchymal stem cells (P-MSCs) proliferation and osteoblastic differentiation in a 3D fibrin matrix. P-MSCs underwent primary culture for three passages before being used to construct cell clots. The fibrin clots were incubated with NPWT under continuous suction at −125 mmHg in a subatmospheric perfusion bioreactor. Clots exposed to atmospheric pressure served as the static control. Compared to the control group, cell proliferation significantly increased in NPWT group after incubation for 3 days. There was no statistical difference in apoptosis rate between two groups. The ALP activity and mineralization of P-MSCs all increased under continuous suction. The expressions of collagen type 1 and transcription factor Cbfa-1 were higher at the 1-, 3-, and 7-day timepoints and the expressions of osteocalcin and integrin β5 were higher at the 3-, and 7-day timepoints in the NPWT group. These results indicate that a short time treatment with NPWT, applied with continuous suction at −125 mmHg, can enhance cellular proliferation of P-MSCs and induce the differentiation toward an osteogenic phenotype. The mechanotransduction molecule integrin β5 was found to be highly expressed after NPWT treatment, which indicates that NPWT may play a positive role in fracture healing through enhance bone formation and decrease bone resorption.
doi:10.1371/journal.pone.0107339
PMCID: PMC4162584  PMID: 25216182
15.  Pressure transduction and fluid evacuation during conventional negative pressure wound therapy of the open abdomen and NPWT using a protective disc over the intestines 
BMC Surgery  2012;12:4.
Background
Negative pressure wound therapy (NPWT) has gained acceptance among surgeons, for the treatment of open abdomen, since very high closure rates have been reported with this method, compared to other kinds of wound management for the open abdomen. However, the method has occasionally been associated with increased development of fistulae. We have previously shown that NPWT induces ischemia in the underlying small intestines close to the vacuum source, and that a protective disc placed between the intestines and the vacuum source prevents the induction of ischemia. In this study we compare pressure transduction and fluid evacuation of the open abdomen with conventional NPWT and NPWT with a protective disc.
Methods
Six pigs underwent midline incision and the application of conventional NPWT and NPWT with a protective disc between the intestines and the vacuum source. The pressure transduction was measured centrally beneath the dressing, and at the anterior abdominal wall, before and after the application of topical negative pressures of -50, -70 and -120 mmHg. The drainage of fluid from the abdomen was measured, with and without the protective disc.
Results
Abdominal drainage was significantly better (p < 0. 001) using NPWT with the protective disc at -120 mmHg (439 ± 25 ml vs. 239 ± 31 ml), at -70 mmHg (341 ± 27 ml vs. 166 ± 9 ml) and at -50 mmHg (350 ± 50 ml vs. 151 ± 21 ml) than with conventional NPWT. The pressure transduction was more even at all pressure levels using NPWT with the protective disc than with conventional NPWT.
Conclusions
The drainage of the open abdomen was significantly more effective when using NWPT with the protective disc than with conventional NWPT. This is believed to be due to the more even and effective pressure transduction in the open abdomen using a protective disc in combination with NPWT.
doi:10.1186/1471-2482-12-4
PMCID: PMC3339517  PMID: 22443416
16.  Negative pressure wound therapy for management of the surgical incision in orthopaedic surgery 
Bone & Joint Research  2013;2(12):276-284.
Objectives
The period of post-operative treatment before surgical wounds are completely closed remains a key window, during which one can apply new technologies that can minimise complications. One such technology is the use of negative pressure wound therapy to manage and accelerate healing of the closed incisional wound (incisional NPWT).
Methods
We undertook a literature review of this emerging indication to identify evidence within orthopaedic surgery and other surgical disciplines. Literature that supports our current understanding of the mechanisms of action was also reviewed in detail.
Results
A total of 33 publications were identified, including nine clinical study reports from orthopaedic surgery; four from cardiothoracic surgery and 12 from studies in abdominal, plastic and vascular disciplines. Most papers (26 of 33) had been published within the past three years. Thus far two randomised controlled trials – one in orthopaedic and one in cardiothoracic surgery – show evidence of reduced incidence of wound healing complications after between three and five days of post-operative NPWT of two- and four-fold, respectively. Investigations show that reduction in haematoma and seroma, accelerated wound healing and increased clearance of oedema are significant mechanisms of action.
Conclusions
There is a rapidly emerging literature on the effect of NPWT on the closed incision. Initiated and confirmed first with a randomised controlled trial in orthopaedic trauma surgery, studies in abdominal, plastic and vascular surgery with high rates of complications have been reported recently. The evidence from single-use NPWT devices is accumulating. There are no large randomised studies yet in reconstructive joint replacement.
Cite this article: Bone Joint Res 2013;2:276–84.
doi:10.1302/2046-3758.212.2000190
PMCID: PMC3884878  PMID: 24352756
Incisional NPWT; Surgical site infection; Single-use NPWT; NPWT; Mechanism of action; Negative pressure wound therapy
17.  Use of Bacteria- and Fungus-Binding Mesh in Negative Pressure Wound Therapy Provides Significant Granulation Tissue Without Tissue Ingrowth 
Eplasty  2014;14:e3.
Objective: Bacteria- and fungus-binding mesh traps and inactivates bacteria and fungus, which makes it interesting, alternative, and wound filler for negative pressure wound therapy (NPWT). The aim of this study was to compare pathogen-binding mesh, black foam, and gauze in NPWT with regard to granulation tissue formation and ingrowth of wound bed tissue in the wound filler. Methods: Wounds on the backs of 8 pigs underwent 72 hours of NPWT using pathogen-binding mesh, foam, or gauze. Microdeformation of the wound bed and granulation tissue formation and the force required to remove the wound fillers was studied. Results: Pathogen-binding mesh produced more granulation tissue, leukocyte infiltration, and tissue disorganization in the wound bed than gauze, but less than foam. All 3 wound fillers caused microdeformation of the wound bed surface. Little force was required to remove pathogen-binding mesh and gauze, while considerable force was needed to remove foam. This is the result of tissue growth into the foam, but not into pathogen-binding mesh or gauze, as shown by examination of biopsy sections from the wound bed. Conclusions: This study shows that using pathogen-binding mesh as a wound filler for NPWT leads to a significant amount of granulation tissue in the wound bed, more than that with gauze, but eliminates the problems of ingrowth of the wound bed into the wound filler. Pathogen-binding mesh is thus an interesting wound filler in NPWT.
PMCID: PMC3899807  PMID: 24501617
blood flow; experimental surgery; negative pressure wound therapy; wound contraction; wound dressing; wound healing
18.  Negative-pressure wound therapy for deep sternal wound infections reduces the rate of surgical interventions for early re-infections† 
OBJECTIVES
To evaluate the outcome of treatment for deep sternal wound infection (DSWI) in a nationwide patient cohort, before and after the introduction of negative-pressure wound therapy (NPWT).
METHODS
This was a population-based cohort of all patients treated for DSWI in Iceland out of 2446 open heart operations performed between 2000 and 2010. Length of hospital stay, survival and reoperations were compared in (i) 23 patients treated with open and/or closed irrigation before August 2005 (conventional treatment, CvT group) and in (ii) 20 patients treated after this time with NPWT as a first-line therapy (NPWT group).
RESULTS
The DSWI rate was 1.8% and did not change during the study period. Demographics were similar for both groups, except for peripheral arterial disease which was less common in the NPWT group. Coagulase-negative staphylococci were also more common (as the only pathogen identified) in the NPWT group (70% vs 30%, P = 0.01). The median length of hospital stay was 43 days in both groups and the sternum could be closed with delayed primary closure in all except 2 patients, one in each group. Eight patients in the CvT group required surgical revision for re-infections, including debridement and rewiring, when compared with 1 patient in the NPWT group (P = 0.02). Furthermore, 6 patients in the CvT group developed late chronic infections of the sternum requiring surgical revision, compared with one in the NPWT group (P = 0.10). The 30-day mortality was not significantly different between groups (4% vs 0%, P > 0.1) and the same was true for 1-year mortality (17% vs 0%, P = 0.11).
CONCLUSIONS
NPWT significantly reduces the risk of early re-infections in patients with DSWI. There was a lower rate of late chronic sternal infections and lower mortality in the NPWT group, but the difference was not statistically significant. We conclude that NPWT should be considered as a first-line treatment for most DSWIs.
doi:10.1093/icvts/ivs254
PMCID: PMC3422957  PMID: 22691377
Deep sternal wound infection (DSWI); Mediastinitis; Cardiac surgery; Negative-pressure wound therapy; Outcome; Re-infection
19.  Effects on heart pumping function when using foam and gauze for negative pressure wound therapy of sternotomy wounds 
Background
Negative pressure wound therapy (NPWT) has remarkable effects on the healing of poststernotomy mediastinitis. Foam is presently the material of choice for NPWT in this indication. There is now increasing interest in using gauze, as this has proven successful in the treatment of peripheral wounds. It is important to determine the effects of NPWT using gauze on heart pumping function before it can be used for deep sternotomy wounds. The aim was to examine the effects of NPWT when using gauze and foam on the heart pumping function during the treatment of a sternotomy wound.
Methods
Eight pigs underwent median sternotomy followed by NPWT at -40, -70, -120 and -160 mmHg, using foam or gauze. The heart frequency, cardiac output, mean systemic arterial pressure, mean pulmonary artery pressure, central venous pressure and left atrial pressure were recorded.
Results
Cardiac output was not affected by NPWT using gauze or foam. Heart frequency decreased during NPWT when using foam, but not gauze. Treatment with foam also lowered the central venous pressure and the left atrial pressure, while gauze had no such effects. Mean systemic arterial pressure, mean pulmonary artery pressure and systemic vascular resistance were not affected by NPWT. Similar haemodynamic effects were observed at all levels of negative pressure studied.
Conclusions
NPWT using foam results in decreased heart frequency and lower right and left atrial filling pressures. The use of gauze in NPWT did not affect the haemodynamic parameters studied. Gauze may thus provide an alternative to foam for NPWT of sternotomy wounds.
doi:10.1186/1749-8090-6-5
PMCID: PMC3031203  PMID: 21232105
20.  Biological Effects of a Disposable, Canisterless Negative Pressure Wound Therapy System 
Eplasty  2014;14:e15.
Objective: Recent developments of negative pressure wound therapy (NPWT) systems have focused on making pumps smaller, lighter, and more portable. The recently introduced PICO system manages wound fluid through a highly breathable film within the dressing, thereby negating the need for a canister, which allows greater mobility and patient concordance. The aim of this study is to compare the biological effects of this system compared to a traditional NPWT system. Methods: Laboratory tests were carried out to demonstrate the fluid handling properties of the PICO™ system. Porcine full thickness defect wounds and sutured incisional wounds were used to compare the biological effects. Wounds were treated with PICO dressings or traditional NPWT dressings and connected to either a PICO device or a traditional NPWT device. Results: The PICO dressing manages exudate predominantly through evaporative loss (up to 85% of all fluid entering the dressing). Both traditional NPWT and the PICO system maintained therapeutic levels of negative pressure in all wounds. Both NPWT systems produced similar effects on wound edge contraction and microvascular blood flow in defect wounds. No significant changes in blood flow or wound contraction were noted in incision wounds for any NPWT combinations tested. Conclusions: The disposable, canisterless PICO NPWT system functions in the same manner as the traditional NPWT systems with regard to fluid handling, pressure transmission to the wound bed, tissue contraction, and changes in blood flow.
PMCID: PMC3977592  PMID: 24741386
Blood flow; dressing; wound; NPWT; vacuum
21.  A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034] 
Trials  2012;13:119.
Background
Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial.
Methods
This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up.
Results
Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months.
Conclusions
This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial.
Trial registration
Current Controlled Trials ISRCTN69032034.
doi:10.1186/1745-6215-13-119
PMCID: PMC3533804  PMID: 22839453
Negative pressure wound therapy; Pressure ulcer; Pilot randomised controlled trial
22.  Negative Pressure Wound Therapy for the Treatment of the Open Abdomen and Incidence of Enteral Fistulas: A Retrospective Bicentre Analysis 
Introduction. The open abdomen (OA) is often associated with complications. It has been hypothesized that negative pressure wound therapy (NPWT) in the treatment of OA may provoke enteral fistulas. Therefore, we analyzed patients with OA and NPWT with special regard to the occurrence of intestinal fistulas. Methods. The present study included all consecutive patients with OA treated with NWPT from April 2010 to August 2011 in two hospitals. Patients' demographics, indications for OA, risk factors, complications, outcome and incidence of fistulas before, during and after NPWT were recorded. Results. Of 81 patients with OA, 26 had pre-existing fistulas and 55 were free from a fistula at the beginning of NPWT. Nine of the 55 patients developed fistulas during (n = 5) or after NPWT (n = 4). Seventy-five patients received ABThera therapy, 6 patients other temporary abdominal closure devices. Only diverticulitis seemed to be a significant predisposing factor for fistulas. Mortality was slightly lower for patients without fistulas. Conclusion. The present study revealed no correlation between occurrence of fistulas before, during, and after NWPT, with diverticulitis being the only risk factor. Fistula formation during NPWT was comparable to reports from literature. Prospective studies are mandatory to clarify the impact of NPWT on fistula formation.
doi:10.1155/2013/730829
PMCID: PMC3830879  PMID: 24285953
23.  The Effects of Variable, Intermittent, and Continuous Negative Pressure Wound Therapy, Using Foam or Gauze, on Wound Contraction, Granulation Tissue Formation, and Ingrowth Into the Wound Filler 
Eplasty  2012;12:e5.
Objective: Negative pressure wound therapy (NPWT) is commonly used in the continuous mode. Intermittent pressure therapy (IPT) results in faster wound healing, but it often causes pain. Variable pressure therapy (VPT) has therefore been introduced to provide a smooth transition between 2 different pressure environments, thereby maintaining the negative pressure environment throughout the therapy. The aim of the present study was to examine the effects of IPT and VPT on granulation tissue formation. Method: A peripheral wound in a porcine model was treated for 72 hours with continuous NPWT (-80 mm Hg), IPT (0 to -80 mm Hg), or VPT (-10 to -80 mm Hg), using foam or gauze as wound filler. Wound contraction and force to remove the wound filler were measured. Biopsies from the wound bed were examined histologically for granulation tissue formation. Results: Intermittent pressure therapy and VPT produced similar results. Wound contraction was more pronounced following IPT and VPT than continuous NPWT. Intermittent pressure therapy and VPT resulted in the formation of more granulation tissue than continuous NPWT. Leukocyte infiltration and tissue disorganization were more prominent after IPT and VPT than after continuous NPWT. Granulation tissue grew into foam but not into gauze, regardless of the mode of negative pressure application, and less force was needed to remove gauze than foam. Conclusions: Wound contraction and granulation tissue formation is more pronounced following IPT and VPT than continuous NPWT. Granulation tissue grows into foam but not into gauze. The choice of negative pressure mode and wound filler is crucial in clinical practice to optimize healing while minimizing pain.
PMCID: PMC3266212  PMID: 22292101
24.  Use of collagenase ointment in conjunction with negative pressure wound therapy in the care of diabetic wounds: a case series of six patients 
Diabetic Foot & Ankle  2015;6:10.3402/dfa.v6.24999.
Background
Diabetic wounds with additional comorbidities are costly, time intensive, and difficult to heal. Often, multiple modalities may be necessary to achieve wound resolution, relying on the synergistic advantage of each therapy to affect wound healing. The selectivity of Clostridium collagenase is physiologically effective at degrading non-viable collagen fibers while preserving living collagen tissue. Additionally, negative pressure wound therapy (NPWT) has long been used to aid wound healing while concurrently depreciating biological wound burden time.
Methods
Six patients were selected from those appearing to our university based limb salvage service. Inclusion criteria included patients with a recurrent mixed fibrotic and granular wound base, in which NPWT was indicated, without exclusion criteria. Patients enrolled were administered clostridial collagenase ointment at each regularly scheduled NPWT dressing change. Patients were followed until healing, with visual representations of wound progression and time to full healing recorded.
Results
Tandem application of these therapies appeared to expedite wound healing by clearing degenerative fibrous tissue and expediting wound granulation without additional complication. Unfortunately, not all patients were able to reach full healing; with two patients experiencing ulcer recurrence, likely a result of their significant comorbid nature.
Conclusion
In our experience, we have noticed a specific subgroup of patients who benefit greatly when collagenase enzymatic debridement therapy is combined with NPWT. It is our belief that this combination therapy combines the molecular clearing of non-viable collagen with the wound granulation necessary to advance complex wounds to the next step in healing despite the current paucity in literature discussing this specific pairing.
doi:10.3402/dfa.v6.24999
PMCID: PMC4309834  PMID: 25630362
diabetes; ulcers; wound healing; negative pressure wound therapy; collagenase
25.  Macroscopic changes during negative pressure wound therapy of the open abdomen using conventional negative pressure wound therapy and NPWT with a protective disc over the intestines 
BMC Surgery  2011;11:10.
Background
Higher closure rates of the open abdomen have been reported with negative pressure wound therapy (NPWT) than with other wound management techniques. However, the method has occasionally been associated with increased development of fistulae. We have previously shown that NPWT induces ischemia in the underlying small intestines close to the vacuum source, and that a protective disc placed between the intestines and the vacuum source prevents the induction of ischemia. In the present study we compare macroscopic changes after 12, 24, and 48 hours, using conventional NPWT and NPWT with a protective disc between the intestines and the vacuum source.
Methods
Twelve pigs underwent midline incision. Six animals underwent conventional NPWT, while the other six pigs underwent NPWT with a protective disc inserted between the intestines and the vacuum source. Macroscopic changes were photographed and quantified after 12, 24, and 48 hours of NPWT.
Results
The surface of the small intestines was red and mottled as a result of petechial bleeding in the intestinal wall in all cases. After 12, 24 and 48 hours of NPWT, the area of petechial bleeding was significantly larger when using conventional NPWT than when using NPWT with the protective disc (9.7 ± 1.0 cm2 vs. 1.8 ± 0.2 cm2, p < 0.001, 12 hours), (14.5 ± 0.9 cm2 vs. 2.0 ± 0.2 cm2, 24 hours) (17.0 ± 0.7 cm2 vs. 2.5 ± 0.2 cm2 with the disc, p < 0.001, 48 hours)
Conclusions
The areas of petechial bleeding in the small intestinal wall were significantly larger following conventional NPWT after 12, 24 and 48 hours, than using NPWT with a protective disc between the intestines and the vacuum source. The protective disc protects the intestines, reducing the amount of petechial bleeding.
doi:10.1186/1471-2482-11-10
PMCID: PMC3095529  PMID: 21529362
negative pressure wound therapy; open abdomen; macroscopic changes; intestinal wall

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