Although there is significant evidence supporting the use of negative pressure wound therapy (NPWT) for the treatment of lower extremity diabetic ulcers, currently available electrically powered NPWT systems are not ideally suited for treating smaller diabetic foot ulcers. The Smart Negative Pressure (SNaP™) Wound Care System is a novel, ultraportable device that delivers NPWT without the use of an electrically powered pump. It was specifically designed to meet the wound care needs of patients with diabetes. The SNaP System is compact, silent, mobile, easy-to-use, and available off-the-shelf. It is fully disposable and may offer other important benefits over electrically powered systems to both the clinician and patient. We review the evidence for use of NPWT for the treatment of diabetic wounds and discuss the potential benefits of this new NPWT technology for patients with diabetes. We also present a case series of four difficult lower extremity diabetic ulcers that were successfully treated with the SNaP System. This study suggests that the SNaP System may be a useful addition to the armamentarium of the diabetic wound care clinician.
Apligraf®; chronic ulcers; diabetic foot ulcers; NPWT; negative pressure wound therapy; SNaP™ System; topical negative pressure; ultraportable negative pressure wound therapy; wound VAC®
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This study was performed to evaluate the results of negative pressure wound therapy (NPWT) in patients with open wounds in the foot and ankle region.
Materials and methods
Using a NPWT device, 16 patients were prospectively treated for soft tissue injuries around the foot and ankle. Mean patient age was 32.8 years (range, 3–67 years). All patients had suffered an acute trauma, due to a traffic accident, a fall, or a crush injury, and all had wounds with underlying tendon or bone exposure. Necrotic tissues were debrided before applying NPWT. Dressings were changed every 3 or 4 days and treatment was continued for 18.4 days on average (range, 11–29 days).
Exposed tendons and bone were successfully covered with healthy granulation tissue in all cases except one. The sizes of soft tissue defects reduced from 56.4 cm2 to 42.9 cm2 after NPWT (mean decrease of 24%). In 15 of the 16 cases, coverage with granulation tissue was achieved and followed by a skin graft. A free flap was needed to cover exposed bone and tendon in one case. No major complication occurred that was directly attributable to treatment. In terms of minor complications, two patients suffered scar contracture of grafted skin.
NPWT was found to facilitate the rapid formation of healthy granulation tissue on open wounds in the foot and ankle region, and thus, to shorten healing time and minimize secondary soft tissue defect coverage procedures.
Negative pressure wound therapy (NPWT) has become a widely used modality for the treatment of complex wounds. However, patient compliance is frequently difficult due to the need to carry a bulky, noisy electronic device. In this issue of Journal of Diabetes Science and Technology, Lerman and colleagues describe a new system that uses no electricity and is about the size of a deck of cards. It is designed to be stored in the clinic and applied almost as simply as a standard wound dressing. Four cases are reviewed to demonstrate that the device is efficacious and helps to encourage patient compliance. No statistically significant outcomes are presented. By removing compliance barriers, this device may encourage more frequent NPWT applications for small wounds.
diabetic foot ulcer; negative pressure wound therapy
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.
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.
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)
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.
negative pressure wound therapy; open abdomen; macroscopic changes; intestinal wall
This is a paper reviewing the National Health Service (NHS) agenda in relation to the use of Negative Pressure Wound Therapy (NPWT) in chronic wound management and assesses the evidence behind it, its cost effectiveness and the outcome it has on patients' satisfaction and life style. Multiple studies over the last 10 years looking at clinical efficacy of NPWT with its cost effectiveness and the implementation of this service in the UK were reviewed. NPWT has showed a reasonable body of evidence to support its usage in chronic wounds with potential positive outcomes on finance and patients' satisfaction. However, the NHS system shows significant variations in the availability and implementation of this useful tool, depending on care providers and resources availabilities. The paper concluded that the NPWT can be a useful source of cutting down costs of chronic wound managements and saving money by its effect on expediting wound healing, which can address a part of the financial crises facing the NHS, however, has to be considered according to specific case needs. There should also be a national standard for the availability and indication of this tool to assure equal opportunities for different patients in different areas in the country.
Objective: The purpose of this article is to describe the treatment of injuries resulting from land mine explosions using a holistic approach that includes gauze-based negative pressure wound therapy (NPWT) and encompasses wound bed preparation, exudate management, and infection control. Method: In the treatment of 3 traumatic injuries, each requiring limb amputation, we describe the application of NPWT using the Chariker-Jeter system, which uses a single layer of saline-moistened antimicrobial gauze laid directly onto the wound bed. A silicone drain is placed on the gauze and then more gauze is placed over the drain to fill the wound. This is then covered with a clear semipermeable film, cut so that there is a 2- to 3-cm border around the wound allowing it to be sealed onto healthy skin. Results: In each of the cases described, we were able to achieve wound closure prior to successful skin grafting, and the patients have recovered well despite the severity of their injuries. Conclusion: We discuss the potential advantages of the Chariker-Jeter system over polyurethane foam as a method of delivering NPWT in highly extensive and irregular-shaped wounds created by land mine explosions while stressing the importance of thorough and effective wound bed preparation.
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.
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.
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.
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.
Primary study selection between systematic reviews is inconsistent, and reviews on the same topic may reach different conclusions. Our main objective was to compare systematic reviews on negative pressure wound therapy (NPWT) regarding their agreement in primary study selection.
This retrospective analysis was conducted within the framework of a systematic review (a full review and a subsequent rapid report) on NPWT prepared by the Institute for Quality and Efficiency in Health Care (IQWiG).
For the IQWiG review and rapid report, 4 bibliographic databases (MEDLINE, EMBASE, The Cochrane Library, and CINAHL) were searched to identify systematic reviews and primary studies on NPWT versus conventional wound therapy in patients with acute or chronic wounds. All databases were searched from inception to December 2006.
For the present analysis, reviews on NPWT were classified as eligible systematic reviews if multiple sources were systematically searched and the search strategy was documented. To ensure comparability between reviews, only reviews published in or after December 2004 and only studies published before June 2004 were considered.
Eligible reviews were compared in respect of the methodology applied and the selection of primary studies.
A total of 5 systematic reviews (including the IQWiG review) and 16 primary studies were analysed. The reviews included between 4 and 13 primary studies published before June 2004. Two reviews considered only randomised controlled trials (RCTs). Three reviews considered both RCTs and non-RCTs. The overall agreement in study selection between reviews was 96% for RCTs (24 of 25 options) and 57% for non-RCTs (12 of 21 options). Due to considerable disagreement in the citation and selection of non-RCTs, we contacted the review authors for clarification (this was not initially planned); all authors or institutions responded. According to published information and the additional information provided, most differences between reviews arose from variations in inclusion criteria or inter-author study classification, as well as from different reporting styles (citation or non-citation) for excluded studies.
The citation and selection of primary studies differ between systematic reviews on NPWT, particularly with regard to non-RCTs. Uniform methodological and reporting standards need to be applied to ensure comparability between reviews as well as the validity of their conclusions.
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.
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.
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.
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.
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.
Current Controlled Trials ISRCTN69032034.
Negative pressure wound therapy; Pressure ulcer; Pilot randomised controlled trial
Higher closure rates of the open abdomen have been reported with negative pressure wound therapy (NPWT) compared with other wound therapy techniques. However, the method has occasionally been associated with increased development of intestinal fistulae. The present study measures microvascular blood flow in the intestinal wall and the omentum before and during NPWT.
Six pigs underwent midline incision and application of NPWT to the open abdomen. The microvascular blood flow in the underlying intestinal loop wall and the omentum was recorded before and after the application of NPWT of −50, −70, −100, −120, −150, and −170 mmHg respectively, using laser Doppler velocimetry.
A significant decrease in microvascular blood flow was seen in the intestinal wall during application of all negative pressures levels. The blood flow was 2.7 (±0.2) Perfusion Units (PU) before and 2.0 (±0.2) PU (*p < 0.05) after application of −50 mmHg, and 3.6 (±0.6) PU before and 1.5 (±0.2) PU (**p < 0.01) after application of −170 mmHg.
In the present study, we show that negative pressures between −50 and −170 mmHg induce a significant decrease in the microvascular blood flow in the intestinal wall. The decrease in blood flow increased with the amount of negative pressure applied. One can only speculate that a longstanding decreased blood flow in the intestinal wall may induce ischemia and secondary necrosis in the intestinal wall, which, theoretically, could promote the development of intestinal fistulae. We believe that NPWT of the open abdomen is a very effective treatment but could probably be improved.
Negative pressure wound therapy; Open abdomen; Microvascular blood flow; Intestinal wall; Omentum
Objectives: Negative pressure wound therapy (NPWT) is a useful therapy in the preparation of wounds prior to application of a split-thickness skin graft (STSG) both “pregraft” and “postgraft” on top of the STSG. Customarily, a foam-based NPWT has been used, but gauze-based therapy is finding an increasing use. Gauze is easy to apply and forgiving of complicated wound geometries so it can be an ideal material in this indication. The aim of this study was to quantitatively assess the clinical efficacy of gauze-based NPWT as an adjunctive therapy to STSG procedures. Methods: A prospective, noncomparative, multicenter evaluation was carried out to assess the performance of gauze-based NPWT. Twenty-one patients had NPWT applied prior to definitive closure by STSG or flap techniques (pregraft group). A further 21 patients underwent an STSG procedure and had gauze-based NPWT placed immediately on top of the STSG (postgraft group). Negative pressure was applied at −80 mm Hg. Results: In the pregraft group, NPWT was used for a median of 12 days. Improvement in quality of wound bed with decreased nonviable tissue (from 20% to 0% median wound area) and increased granulation tissue (from 20% to 90% median wound area) was observed. In the postgraft group, median duration of therapy was 5 days at which point median percentage skin graft-take was 96%. Conclusions: Gauze-based NPWT appears to be an effective addition to the care and management of wounds intended for definitive closure by STSG.
The use of Negative Pressure Wound Therapy (NPWT) for temporary abdominal closure of open abdomen (OA) wounds is widely accepted. Published outcomes vary according to the specific nature and the aetiology that resulted in an OA. The aim of this study was to evaluate the effectiveness of a new NPWT system specifically used OA resulting from abdominal trauma.
A prospective study on trauma patients requiring temporary abdominal closure (TAC) with grade 1or 2 OA was carried out. All patients were treated with NPWT (RENASYS AB Smith & Nephew) to achieve TAC. The primary outcome measure was time taken to achieve fascial closure and secondary outcomes were complications and mortality.
A total of 20 patients were included. Thirteen patients (65%) achieved fascial closure following a median treatment period of 3 days. Four patients (20%) died of causes unrelated to NPWT. Complications included fistula formation in one patient (5%) with spontaneous resolution during NPWT), bowel necrosis in a single patient (5%) and three cases of infection (15%). No fistulae were present at the end of NPWT.
This new NPWT kit is safe and effective and results in a high rate of fascial closure and low complication rates in the severely injured trauma patient.
Negative Pressure Wound Therapy (NPWT); Grade 1 and 2 open abdomen; Abdominal trauma; Fascial closure
Right ventricular heart rupture is a devastating complication associated with negative pressure wound therapy (NPWT) in cardiac surgery. The use of a rigid barrier has been suggested to offer protection against this lethal complication, by preventing the heart from being drawn up and damaged by the sharp edges of the sternum. The aim of the present study was to investigate whether a rigid barrier protects the heart and lungs against injury during NPWT.
Sixteen pigs underwent median sternotomy followed by NPWT at -120 mmHg for 24 hours, in the absence (eight pigs) or presence (eight pigs) of a rigid plastic disc between the heart and the sternal edges. The macroscopic appearance of the heart and lungs was inspected after 12 and 24 hours of NPWT.
After 24 hours of NPWT at -120 mmHg the area of epicardial petechial bleeding was 11.90 ± 1.10 cm2 when no protective disc was used, and 1.15 ± 0.19 cm2 when using the disc (p < 0.001). Heart rupture was observed in three of the eight animals treated with NPWT without the disc. Lung rupture was observed in two of the animals, and lung contusion and emphysema were seen in all animals treated with NPWT without the rigid disc. No injury to the heart or lungs was observed in the group of animals treated with NPWT using the rigid disc.
Inserting a rigid barrier between the heart and the sternum edges offers protection against heart rupture and lung injury during NPWT.
Objective: The treatment of patients with cancer has advanced into a complex, multimodal approach incorporating surgery, radiation, and chemotherapy. Managing wounds in this population is complicated by tumor biology, the patient's disease state, and additional comorbidities, some of which may be iatrogenic. Radiation therapy, frequently employed for local-regional control of disease following surgical resection, has quantifiable negative healing effects due to local tissue fibrosis and vascular effects. Chemotherapeutic agents, either administered alone or as combination therapy with surgery and radiation, may have detrimental effects on the rapidly dividing tissues of healing wounds. Overall nutritional status, often diminished in patients with cancer, is an important aspect to the ability of patients to heal after surgical procedures and/or treatment regimens. Methods: An extensive literature search was performed to gather pertinent information on the topic of wound healing in patients with cancer. The effects that surgical procedures, radiation therapy, chemotherapy, and nutritional deficits play in wound healing in these patients were reviewed and collated. Results: The current knowledge and treatment of these aspects of wound healing in cancer patients are discussed, and observations and recommendations for optimal wound healing results are considered. Conclusion: Although wound healing may proceed in a relatively unimpeded manner for many patients with cancer, there is a potential for wound failure due to the nature and effects of the oncologic disease process and its treatments.
Negative pressure wound therapy (NPWT) is widely applied, although the evidence base is weak. Previous reviews on medical interventions have shown that conclusions based on published data alone may no longer hold after consideration of unpublished data. The main objective of this study was to identify unpublished randomised controlled trials (RCTs) on NPWT within the framework of a systematic review.
RCTs comparing NPWT with conventional wound therapy were identified using MEDLINE, EMBASE, CINAHL and The Cochrane Library. Every database was searched from inception to May 2005. The search was updated in December 2006. Reference lists of original articles and systematic reviews, as well as congress proceedings and online trial registers, were screened for clues to unpublished RCTs. Manufacturers of NPWT devices and authors of conference abstracts were contacted and asked to provide study information. Trials were considered nonrandomised if concealment of allocation to treatment groups was classified as "inadequate". The study status was classified as "completed", "discontinued", "ongoing" or "unclear". The publication status of completed or discontinued RCTs was classified as "published" if a full-text paper on final study results (completed trials) or interim results (discontinued trials) was available, and "unpublished" if this was not the case. The type of sponsorship was also noted for all trials.
A total of 28 RCTs referring to at least 2755 planned or analysed patients met the inclusion criteria: 13 RCTs had been completed, 6 had been discontinued, 6 were ongoing, and the status of 3 RCTs was unclear. Full-text papers were available on 30% of patients in the 19 completed or discontinued RCTs (495 analysed patients in 10 published RCTs vs. 1154 planned patients in 9 unpublished RCTs). Most information about conference abstracts and unpublished study information referring to trials that were unpublished at the time these documents were generated was obtained from the manufacturer Kinetic Concepts Inc. (KCI) (19 RCTs), followed by The Cochrane Library (18) and a systematic review (15). We were able to obtain some information on the methods of unpublished RCTs, but results data were either not available or requests for results data were not answered; the results of unpublished RCTs could therefore not be considered in the review. One manufacturer, KCI, sponsored the majority of RCTs (19/28; 68%). The sponsorship of the remaining trials was unclear.
Multi-source comprehensive searches identify unpublished RCTs. However, lack of access to unpublished study results data raises doubts about the completeness of the evidence base on NPWT.
Negative pressure wound therapy (NPWT) is commonly used as a bolster for skin grafts. The technique offers the benefit of negative pressure as well as reduced dressing changes. Skin grafting of the hand provides a unique challenge, and currently, the only commercially available NPWT hand dressings are adult-sized, precluding their use in small children. We present our custom NPWT “mitten” technique for use with skin grafts on the pediatric hand.
Vacuum-assisted closure (VAC®); Pediatric hand; Skin graft; Negative pressure wound therapy (NPWT); Bolster
Deep sternal infections, also known as poststernotomy mediastinitis, are a rare but often fatal complication in cardiac surgery. They are a cause of increased morbidity and mortality and have a significant socioeconomic aspect concerning the health system. Negative pressure wound therapy (NPWT) followed by muscular pectoralis plasty is a quite new technique for the treatment of mediastinitis after sternotomy. Although it could be demonstrated that this technique is at least as safe and reliable as other techniques for the therapy of deep sternal infections, complications are not absent. We report about our experiences and complications using this therapy in a set of 54 patients out of 3668 patients undergoing cardiac surgery in our institution between January 2005 and April 2007.
Chronic non-healing wounds, such as venous stasis ulcers, diabetic ulcers, and pressure ulcers are serious unmet medical needs that affect a patient’s morbidity and mortality. Common pathogens observed in chronic non-healing wounds are Staphylococcus including MRSA, Pseudomonas, Enterobacter, Stenotrophomonas, and Serratia spp. Topical and systemically administered antibiotics do not adequately decrease the level of bacteria or the associated biofilm in chronic granulating wounds and the use of sub-lethal concentrations of antibiotics can lead to resistant phenotypes. Furthermore, topical antiseptics may not be fully effective and can actually impede wound healing. We show 5 representative examples from our more than 30 clinical case studies using NeutroPhase® as an irrigation solution with chronic non-healing wounds with and without the technique of negative pressure wound therapy (NPWT). NeutroPhase® is pure 0.01% hypochlorous acid (i.e. >97% relative molar distribution of active chlorine species as HOCl) in a 0.9% saline solution at pH 4-5 and is stored in glass containers. NovaBay has three FDA cleared 510(k)s. Patients showed a profound improvement and marked accelerated rates of wound healing using NeutroPhase® with and without NPWT. NeutroPhase® was non-toxic to living tissues.
NeutroPhase®; hypochlorous acid; chronic non-healing wounds; 510(k); negative pressure wound therapy (NPWT)
In 1997, supported by experimental work, Argenta published a clinical report describing a variety of complicated wounds whose treatment responded successfully to negative pressure dressings using a vacuum-assisted closure system (VAC) (Kinetic Concepts Inc., San Antonio, TX). This system has been successfully used in the fields of orthopaedics and traumatology, general surgery, plastic and reconstructive surgery and gynaecology/obstetrics for a large variety of complicated wounds located in several regions, particularly in the torso and extremities. To the best of our knowledge, the use of the VAC therapy in treating free flaps surgical wounds has not been discussed in the literature. Since 2009 at the Novara Major Hospital, we have been using the VAC therapy in selected cases for difficult and complicated wounds of the maxillofacial region. The purpose of this study is to describe and discuss three cases undergoing VAC therapy followed by loco-regional flaps in the management of exposed bone after fibular free flap. The advantages and disadvantages of VAC therapy in treating complicated wounds have been reported by several studies; compared with conventional wet-to-dry dressings, this system eliminates interstitial oedema, exudates and debrides while increasing blood perfusion leading to a more rapid promotion of wound healing with less bacterial loading. Although surgical debridement, wet-to-dry dressing changes and antibiotic treatment are the mainstay in managing maxillofacial wounds, VAC therapy can be used to obtain primary closure or to prepare the wound bed until definitive reconstruction is carried out. In our opinion, the VAC technique is an innovative therapy, and at our institution represents the standard of care for the majority of complicated wounds.
Fibular free flap; Subatmospheric pressure; Maxillofacial wound; VAC therapy
Sternal wound infection remains a serious potential complication after cardiac surgery. A recent development for preventing wound complications after surgery is the adjunctive treatment of closed incisions with negative pressure wound therapy. Suggested mechanisms of preventive action are improving the local blood flow, removing fluids and components in these fluids, helping keep the incision edges together, protecting the wound from external contamination and promoting incision healing. This work reports on our initial evaluation and clinical experience with the Prevena™Incision Management System, a recently introduced new negative pressure wound therapy system specifically developed for treating closed surgical incisions and helping prevent potential complications. We evaluated the new treatment on sternal surgical incisions in patients with multiple co-morbidities and consequently a high risk for wound complications.
The Prevena™incision management system was used in 10 patients with a mean Fowler risk score of 15.1 [Range 8-30]. The negative pressure dressing was applied immediately after surgery and left in place for 5 days with a continuous application of -125 mmHg negative pressure. Wounds and surrounding skin were inspected immediately after removal of the Prevena™ incision management system and at day 30 after surgery.
Wounds and surrounding skin showed complete wound healing with the absence of skin lesions due to the negative pressure after removal of the Prevena™ dressing. No device-related complications were observed. No wound complications occurred in this high risk group of patients until at least 30 days after surgery.
The Prevena™system appears to be safe, easy to use and may help achieve uncomplicated wound healing in patients at risk of developing wound complications after cardiothoracic surgery.
incision; wound healing; negative pressure wound therapy; cardiac surgery; median sternotomy