This policy was initially developed from a 2000 TEC Assessment (1) that evaluated negative pressure therapy of pressure ulcers, venous ulcers, and diabetic ulcers. The TEC Assessment concluded that the evidence was insufficient to permit conclusions regarding the effect of the technology on health outcomes and that the efficacy of negative pressure therapy compared to standard wound management should be determined by high-quality clinical trials that contain the following features:
- enrollment of a patient population with ulcers refractory to standard treatment after an appropriate period of optimal wound management;
- randomized assignment to treatment group;
- treatment in the control arm that includes all of the main components of optimal wound care, e.g., debridement, irrigation, whirlpool treatments, and wet-to-dry dressings;
- outcome measure(s) that represent clinically important endpoints, such as the percent of patients with complete healing or the percent of patients who require skin grafting.
In 2004, the Blue Cross and Blue Shield Technology Evaluation Center (TEC) prepared a systematic review for the Agency for Healthcare Research and Quality (AHRQ) that concluded that available published trials “did not find a significant advantage for the intervention on the primary endpoint, complete healing, and did not consistently find significant differences on secondary endpoints and may have been insufficiently powered to detect differences.” (2)
Literature updates for this policy have focused on comparative trials with the features described in the TEC Assessment, e.g., enrollment of patients with ulcers refractory to standard treatment, randomization, optimal standard wound care treatment in the control arm, and clinically important endpoints. The most recent literature search using the MEDLINE database was performed through November 2011. Following is a summary of key literature to date.
Negative pressure wound therapy (NPWT) devices can be classified as either powered, i.e., requiring an external power source, or non-powered, i.e., mechanical. The vast majority of evidence is for powered devices and the main discussion of evidence refers to powered devices. The evidence on non-powered devices will be discussed separately following the review of evidence on powered devices.
Various Wound Types
A Cochrane review of NPWT for treatment of chronic wounds was published in 2008. (3) A total of 7 trials involving 205 participants were reviewed. The 7 trials compared NPWT with 5 different comparator treatments (gauze soaked in either 0.9% saline or Ringer's solution, hydrocolloid gel plus gauze, a treatment package comprising papain-urea topical treatment, and cadexomer iodine or hydrocolloid, hydrogels, alginate and foam). The authors reported that the data do not show that NPWT significantly increases the healing rate of chronic wounds compared with comparators and concluded that “trials comparing NPWT with alternative treatments for chronic wounds have methodologic flaws and data do demonstrate a beneficial effect of NPWT on wound healing; however, more, better quality research is needed.”
A 2009 Agency for Healthcare Research and Quality (AHRQ) technology assessment on negative pressure wound therapy devices was performed by ECRI Institute for the Centers for Medicare and Medicaid Services (CMS). (4) This technology assessment was looking primarily for “therapeutic distinctions” between the various NPWT devices on the market. The Medicare Improvements for Patient and Providers Act (MIPPA) of 2008 called for an evaluation of the HCPCS coding decisions for these devices, so this assessment was performed to inform that evaluation. The AHRQ assessment found that there were no studies showing a therapeutic distinction between these devices.
Excerpts from the summary are noted below:
We identified a total of 23 other systematic reviews, all published between 2000 and 2008, that covered NPWT devices. These reviews included studies reporting data on NPWT for patients with a broad range of wound types and focused on comparison to other wound treatments (gauze, bolster dressings, wound gels, alginates, and other topical therapies). The systematic reviews of NPWT reveal several important points about the current state of the evidence on this technology. First, all of the systematic reviews noted the lack of high-quality clinical evidence supporting the advantages of NPWT compared to other wound treatments. The lack of high-quality NPWT evidence resulted in many systematic reviewers relying on low-quality retrospective studies to judge the efficacy of this technology. Second, no studies directly comparing different NPWT components (such as foam vs. gauze dressings) were identified by any of the reviewers.
The authors of this report also comment on a 2008 study by Peinemann and colleagues (5) as follows:
In their systematic review of clinical studies of NPWT, Peinemann et al. sought to identify unpublished completed or discontinued [randomized controlled trials] RCTs to gain a broader knowledge of the NPWT evidence. The authors were concerned that previous systematic review conclusions on efficacy and safety based on published data alone may no longer hold after consideration of unpublished data. The authors invited two NPWT device manufacturers KCI. (V.A.C.®) and BlueSky Medical Group Inc. (Versatile 1 Wound Vacuum System) and authors of conference abstracts to provide information on study status and publication status of sponsored trials. Responses were received from 10 of 17 (59%) authors and both manufacturers. BlueSky Medical Group Inc., however, had not sponsored relevant [randomized, controlled trials] and only provided case reports. The authors determined that of 28 [randomized, controlled trials], 13 had been completed, 6 had been discontinued, 6 were ongoing, and the status of 3 could not be determined. Nine trials were unpublished, and no results were provided by the investigators. Peinemann et al. concluded that the "lack of access to unpublished study results data raises doubts about the completeness of the evidence base on NPWT.”
In a 2011 publication, Peinemann and Sauerland updated their systematic review of NPWT for the treatment of acute or chronic wounds with a literature search performed in November 2010. (6) They found 9 RCTs in addition to the 12 covered by earlier reviews; 5 of the 9 new trials involved NPWT systems that were not on the market. Only 5 of the 9 new reports assessed the frequency of complete wound closure (Peinemann and Sauerland’s primary outcome measure), and a statistically significant effect in favor of NPWT was found in only 2 trials. Due to high potential for bias and because diverse types of wounds were treated, interpretation of results for 8 of the 9 trials was found to be limited. Peinemann and Sauerland concluded that although there may be a positive effect of NPWT, they did not find clear evidence that wounds heal any better or worse with NPWT than with conventional treatment, and good RCTs are still needed.
Examples of the literature include a 2004 study by Moues et al. (7) on the time to readiness for surgical closure, among patients with full-thickness wounds of various etiologies. Log-rank test analysis of Kaplan-Meier time to readiness did not show any statistically significant differences between groups. The median time to readiness for surgical closure was 6 days for negative pressure therapy patients and 7 days for conventionally treated patients (p=0.19). Braakenburg and colleagues compared NPWT using the V.A.C.® system (n=32) with conventional moist wound therapy (n=33) in patients with different types of wounds (operation wounds, diabetic ulcers, pressure sores) that ranged in duration from less than 48 hours old to longer than 6 weeks. (8) Twenty-six (81%) NPWT patients and 19 (58%) conventional therapy patients reached an endpoint of wound healing (p<0.05). The median healing time was 4 days shorter in the NPWT group (16 days) compared with controls (20 days), a non-significant difference. Substantial, unaccounted loss to follow-up (NPWT, 19%; controls, 36%) and ill-defined wound characteristics confound the results. A publication from 2008 describes an RCT of NPWT carried out in India using a locally constructed device. (9) In this study, 48 patients with diabetic foot ulcers, pressure ulcers, cellulitis/fasciitis, and “other” were randomized to NPWT or moist dressings. One patient in the NPWT group and 12 in the conventionally treated group were lost to follow-up. No statistically significant differences in time to closure were observed between groups except in a subset analysis of pressure ulcers (mean 10 [+/- 7.11] days for the treatment group and 27 [+/- 10.6] days in controls [p=0.05]). The high drop-out rate prevents drawing clear conclusions from this study.
Gregor and colleagues included nonrandomized trials in their 2008 review if there was a concurrent control group, and concluded that though there is some indication that NPWT may improve wound healing, the evidence is insufficient to clearly prove an additional benefit. They note that the large number of prematurely terminated and unpublished trials of the therapy is reason for concern. (10) Authors of other systematic reviews, even if they conclude that there is evidence of efficacy, call for larger, high-quality studies. (11-13)
Representative literature includes a small trial that randomized 24 patients with pressure ulcers of the pelvic region to negative pressure therapy or standard wound care. (14) All patients with pelvic pressure sores were eligible for enrollment and were not required to be refractory to standard treatment. There were no significant group differences for the main outcome measure, time to 50% reduction of wound volume (27 +/- 10 days in the negative pressure therapy group and 28 +/- 7 days in the control group). Limitations include the small number of patients in the study, the possibility that the control group may not have received optimal wound management, and a main outcome measure of 50% reduction in wound size, which is not necessarily a clinically important outcome when compared with other potential outcomes such as complete wound healing.
A retrospective multicenter study measured wound surface over a 28-day observation period in hospitalized patients with spinal cord injuries and stage III/IV pelvic pressure ulcers treated with standard wound care (n=53) or NPWT (n=33). (15) Over the 28-day period, 59 patients’ wounds were classified as healing and 27 as nonhealing. The proportion of patients demonstrating a decrease in wound surface area (healing subgroup) was not significantly different between the NPWT and standard care groups.
Lower Extremity Ulcers
The largest study of NPWT for diabetic foot ulcers is a 2008 multicenter randomized controlled comparison of NPWT versus moist wound therapy by Blume et al. (16) Included were 342 patients with Wagner’s stage 2 or 3 foot ulcers equal to or greater than 2 cm; the chronicity of the ulcers was not described. Based on intent-to-treat analysis, a greater proportion of NPWT-treated foot ulcers achieved the primary endpoint of complete ulcer closure (43.2% vs. 28.9%) within the 112-day active treatment phase. For the 240 patients (72%) who completed the active treatment phase, 60.8% of NPWT-treated ulcers achieved ulcer closure compared to 40.0% of ulcers treated with moist wound therapy. NPWT patients experienced significantly fewer secondary amputations (4.1% vs. 10.2%). Although this study is limited by 28% loss to follow-up, and chronicity of the ulcers was not described, it is of higher quality than the vast majority of literature in this area..
Vuerstaek and colleagues compared the efficacy of NPWT using the V.A.C.® system (n=30) with conventional moist wound care (n=30) in patients hospitalized with chronic venous and/or arterial leg ulcers of greater than 6 months’ duration. (17) Full-thickness punch skin grafts from the thigh were applied, followed by 4 days of negative pressure wound therapy (NPWT) or conventional care to assure complete graft adherence. Each group then received standard care with nonadhesive dressings and compression therapy until complete healing (primary outcome) occurred. The median time to complete healing was 29 days with NPWT and 45 days in the controls (p=0.0001). Ninety percent of the ulcers treated with NPWT healed within 43 days, compared with 48% in the control group. These results suggest NPWT significantly hastened wound healing, but the use of skin autografts makes it difficult to discern the contribution of NPWT to the primary outcome.
Traumatic and Surgical Wounds
Three RCTs with more than 50 patients, 4 comparative studies with non-concurrent controls, and numerous case series have been identified. These studies describe a variety of wound types treated over periods ranging from several days to several months.
The largest trial on surgical wounds is a 2011 report from an investigator-initiated, industry-sponsored multicenter RCT of in-patient NPWT for closed surgical incisions. (18) (A preliminary report was published in 2006.) (19) Included were 249 blunt trauma patients with 263 high-risk fractures (tibial plateau, pilon, calcaneus) requiring surgical stabilization. The patients were randomized to NPWT applied to the closed surgical incision or to standard postoperative dressings. All patients were maintained as inpatients until wound drainage was minimal, at which time the NPWT was discontinued (mean 59 hours; range 21 to 213 hours). Patients in the NPWT group were ready for discharge in 2.5 days compared with 3.0 days for the control group; this was not significantly different. The NPWT-treated group had significantly fewer infections than the control group (10% vs. 19% of fractures, p=0.049). Wound dehiscence after discharge was observed less frequently in the NPWT group than the control group (8.6% vs. 16.5%). These results may reflect the efficacy of short-term use of NPWT under highly controlled conditions of inpatient care, but do not address the effectiveness of NPWT in the outpatient setting.
In 2005, Armstrong and colleagues (20) reported an RCT of NPWT using the V.A.C. ® system (n=77) and standard moist wound care (n=85) to treat partial foot amputation wounds (average wound duration 1.5 months) in diabetic patients. Forty-three (56%) of NPWT patients achieved complete closure during the 16-week assessment period versus 33 (39%) of controls (p=0.040). Log-rank analysis showed the rate of complete closure was significantly faster with NPWT than in controls. The frequency and severity of adverse events, most commonly infection (32% in both groups), were similar. Intention-to-treat analysis was reported, but substantial unaccounted loss to follow-up (23%), lack of allocation concealment in randomization, and between group differences in wound care limits these results. The authors reported a reanalysis of these data to examine the possible role of wound chronicity on healing in a later paper. (21) This analysis revealed no significant difference in the proportion of acute and chronic wounds that achieved complete wound closure with either therapy, although the Kaplan-Meier curve demonstrated statistically faster (p=0.03) healing in the NPWT group in both acute and chronic wounds. While these findings suggest that NPWT improves outcomes compared to standard care, this was a post-hoc, unplanned reanalysis of data from a study with several flaws and potential biases that limit validity.
Chio and Agrawal published results of a randomized trial of 54 patients comparing NPWT with a static pressure dressing for healing of the radial forearm free flap donor site in 2010. (22) There were no statistically significant differences in wound complications or graft failure (percentage of area for graft failure was 7.2% for negative pressure and 4.5% for standard dressing). The authors concluded that negative pressure dressing does not appear to offer a significant improvement over standard pressure dressing in healing of the radial forearm free flap donor site.
Non-Randomized Controlled Studies
A 2002 trial by Doss et al. was a retrospective comparison of negative pressure therapy with conventional wound management for patients with post-sternotomy osteomyelitis and featured a non-concurrent control group. (23) Treatment assignment was at the discretion of the treating surgeon and was mainly dependent on the time period during which the patient was treated. Treatment duration was shorter for the NPWT (17.2 vs. 22.9 days), as was length of hospital stay (27.2 vs. 33.0 days). A 2011 analysis of NPWT for patients with infected sternal wounds concluded that, based on 6 articles and 321 patients, NPWT resulted in a decrease of 7.2 days in hospital length of stay with no significant impact on mortality. (24)
Yang and colleagues retrospectively reviewed records of 34 patients who underwent NPWT after fasciotomy wounds for traumatic compartment syndrome of the leg and compared them with matched historic controls measuring time to definitive closure (delayed closure with sutures or skin graft). (25) Average time to definitive closure for both lateral and medial wounds was 6.7 days in the NPWT group (68 wounds in 34 patients) and 16.1 days in the controls (70 wounds in 34 patients) (p<0.05). In another study of fasciotomy wounds, Zannis et al. retrospectively reviewed records of patients with upper and lower extremity fasciotomy wounds treated over a 10-year period. (26) Of 142 upper extremity wounds, 74 received conventional treatment and 68 were treated with NPWT. Of 662 lower extremity wounds, 196 received only conventional treatment, 370 received only NPWT, and 96 received both treatments. The authors report a higher rate of primary closure using NPWT (82.7%) versus wet-to-dry dressings for all lower extremity wounds, and 55.6% (p<0.03) for upper extremity wounds. Lack of a contemporaneous control group limits the application of these findings.
Shilt et al. compared outcomes for 16 children treated with NPWT after lawnmower injuries to outcomes for 15 historic controls treated with wet-dry or Xeroform dressings. (27) There were no differences in infection rates between groups, and patients treated with NPWT had longer hospital stays. Fifty-three percent of the controls required a free flap versus 19% of the NPWT group. The small number of subjects in this study limits interpretation of the results, as does the lack of a contemporaneous control group.
A large number of case series are reported. These include patients treated with NPWT for deep wound infections following spine surgery, (28, 29) surgical site infections in the groin after arterial surgery, (30) and mediastinitis after sternotomy. (31) The FDA has not cleared any NPWT devices for use in children; however, a number of case reports and very small case series report experience with infants and small children, most commonly for treatment of sternal wounds. (32)
Canadian researchers studied predictors of failure of NPWT closure of sternotomy wounds. (33) Twelve risk factors for impaired wound healing were identified before data collection to retrospectively evaluate predictors of NPWT failure. Of 37 patients treated with NPWT between January 1997 and July 2003, 8 patients failed NPWT. Of the 12 risk factors, 3 were found to be predictive of poor outcome: bacteremia, wound depth of 4 or more cm, and high degree of bony exposure and sternal instability. The authors advise that prospective randomized studies are needed to validate these hypotheses.
Schmelzle et al. report a group of patients who may not benefit from NPWT. Schmelzle et al. reviewed records of 49 patients with open abdomen for more than 7 days due to secondary peritonitis who underwent NPWT. (34) Fascial closure could be accomplished in only 11 patients and complications occurred in 43 patients. Re-explorations after starting NPWT were associated with the occurrence of enterocutaneous fistula and were of prognostic value regarding the rate of fascial closure. The authors advise that further studies are needed to evaluate whether this subgroup really benefits from NPWT.
A 2007 Cochrane review of the literature on NPWT for treatment of partial thickness burns found only one RCT that satisfied the inclusion criteria, and the methodologic quality of the trial was poor. (35) The authors concluded that there is a “paucity of high quality [randomized, controlled trials] on NPWT for partial thickness burn injury with insufficient sample size and adequate power to detect differences, if there are any, between NPWT and conventional burn wound therapy dressings.”
In 2011, Petkar and colleagues published a randomized controlled trial comparing 4 days of NPWT with a locally constructed device versus conventional dressing methods for split-thickness skin grafts. (36) Forty grafts in 30 burn patients were included in the study. The percentage of graft take at 9 days after surgery was assessed by consensus of the treating plastic surgery unit after gross examination and was significantly greater in the NPWT-treated grafts (96.7% vs. 87.5%). The mean duration of continued dressing on the grafted area was 8 days for NPWT and 11 days in controls. The duration of therapy was a clinical decision made by the surgeon, taking into account the adherence and stability of the graft.
An expert panel convened to develop evidence-based recommendations for the use of NPWT reported that the evidence base in 2011 was strongest for the use of NPWT on skin grafts and weakest as a primary treatment for burns. (37)
Non-powered NPWT Devices
One ultraportable, non-powered (mechanical) gauze-based NPWT device (SNaP Wound Care System) designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, subacute wounds and diabetic and pressure ulcers became available in 2009.
In 2011, Armstrong and colleagues reported results of a planned interim analysis of an RCT comparing SNaP and the KCI Wound VAC Therapy System for the treatment of chronic lower extremity wounds. (38) Patients had venous or diabetic ulcers with surface area between 1 and 100 cm2 and diameter less than 10 cm and present more than 30 days despite appropriate care. Dressings were changed per manufacturer direction, 2 times per week in the SNaP group and 3 times per week in the VAC group. Analysis after 65 patients had enrolled was based on 53 patients who had completed at least 4 weeks of therapy, 27 SNaP and 26 VAC. This analysis found no significant between group differences in the proportion of subjects healed or the percent of wound size reduction. Survey data indicated that dressing changes required less time, and use of the SNaP device interfered less with mobility and activity than the VAC device. This study is limited by differences in wound size and duration at baseline and the lack of comparison with standard treatment protocols.
A retrospective study with historical controls compared NPWT using the SNaP device (n=28) with wound care protocols that included the use of Apligraf, Regranex, and skin grafting (n=42) for treatment of lower extremity ulcers. (39) Seven patients (25%) in the SNaP-treated group could not tolerate the treatment and were discontinued from the study because of complications (allergic skin reaction , wound infection , bleeding after debridement preventing reapplication , worsening lower extremity edema , and the development of maceration severe enough to require discontinuation [n=3]) and were considered treatment failures. Between-group estimates of time-to-wound healing by Kaplan-Meier analysis favored the SNaP treatment group. This study is limited by the use of historical controls, the multiple modalities used in treatment of controls, and the large number of dropouts. The authors noted that patients in the SNaP-treated group may have benefited from being in an experimental environment, particularly because wounds in this group were seen twice per week compared to variable follow-up in the historical controls.
Other publications have described use of the SNaP device in case series with small numbers of patients, fewer than 15 patients. (40-42) Landsman comments that by removing compliance barriers, this device may encourage more frequent use of NPWT for small wounds. (41)
Clinical Input Received through Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
In response to requests, input was received from 2 physician specialty societies and 3 academic medical centers while this policy was under review in 2010. The input was near uniform in support of a therapeutic trial of NPWT for chronic pressure ulcers that have failed to heal, for traumatic or surgical wounds that have failed to close when there is exposed bone, cartilage, tendon, or foreign material within the wound, and for non-healing wounds in patients with underlying clinical conditions known to negatively impact wound healing. The majority of the input agreed that therapeutic trials of NPWT for other acute or chronic wounds would be not medically necessary.
Anecdotal and limited clinical trials demonstrate that there is a subset of problematic wounds where the use of negative pressure wound therapy (NPWT) may provide a significant clinical benefit. However, due to clinical variability and the limited data, it is not possible to determine prospectively which wounds are most likely to respond favorably to NPWT. Therefore, the policy statement indicates that a therapeutic trial of NPWT of not less than 14 days may be considered medically necessary for chronic wounds that have failed to heal despite intense conventional wound therapy for at least 90 days, or for those acute and chronic wounds that have a high probability of failure to heal due to compounding factors involving the wound and the patient. Continued use of NPWT requires objective evidence of wound healing such as the development of healthy granulation tissue and progressive wound contracture.
Use of NPWT for other wounds is considered not medically necessary as these wounds are likely to heal with conventional wound management, i.e., the evidence does not demonstrate an incremental improvement in wound healing with use of the NPWT for these cases.
Reports with small numbers of patients, including planned interim analysis of a comparative trial, using the non-powered (mechanical) gauze-based NPWT system are insufficient to draw conclusions about its impact on net health outcome, both for the device itself and in comparison with current care. There are important unanswered questions about efficacy and tolerability. Well-designed comparative studies with large numbers of patients are needed. Since the impact on net health outcome compared to existing technology is not known, this is considered investigational.
Practice Guidelines and Position Statements
Guidelines for the prevention of infections associated with combat-related injuries were endorsed in 2011 by the Infectious Diseases Society of America and the Surgical Infection Society. (43) The guidelines provide a IB recommendation (strong recommendation, moderate-quality evidence) that NPWT should be used in the management of open wounds (excluding central nervous system (CNS) injuries) to include during aeromedical evacuation of patients.
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) stated in 2009 that current evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is inadequate in quality and quantity, and clinicians should make special arrangements for audit of the management of all patients with an open abdominal wound. (44)
The 2005 guidance on the management of pressure ulcers in primary and secondary care from the Royal College of Nursing and NICE stated that topical negative pressure treatment was only assessed in one trial with a small sample size and methodologic limitations; while the trial results suggested that topical negative pressure treatment may increase healing rates of pressure ulcers compared with saline gauze dressings, the findings must be viewed with extreme caution. “Practitioners ought to make patients aware of the limited trial-based evidence for the effectiveness of topical negative pressure for pressure ulcer healing and that further research is required to validate the preliminary findings.” (45)
The 2007 guidelines from the American Society of Plastic Surgeons (ASPS) states that maintaining a moist environment, while simultaneously removing soluble factors detrimental to wound healing might logically provide optimal conditions for wound healing. (46) Classic dressings include gauze, foam, hydrocolloid, and hydrogels. Fluid-handling mechanisms include absorption, gelling, retention, and vapor transmission. Bioactive dressings include topical antimicrobials, bioengineered composite skin equivalent, bilaminar dermal regeneration template, and recombinant human growth factor. Finally, negative pressure wound therapy (NPWT) is a mechanical treatment that uses negative pressure to remove wound exudate. Although the wound care literature is rife with uncontrolled studies reporting the effectiveness of negative pressure wound therapy, few prospective randomized trials exist. Despite a lack of strong evidence to support its use, negative pressure wound therapy has gained wide acceptance by multiple specialties for a myriad of wounds.
Included in the American College of Foot and Ankle Surgeons (ACFAS) 2006 guideline on diabetic foot disorders is the following information on NPWT: (47) Negative pressure wound therapy (NPWT) has become a common adjunctive treatment modality for diabetic foot ulcerations. Use of a vacuum-assisted closure® device (V.A.C.®, KCI, San Antonio, TX) promotes wound healing through the application of topical, subatmospheric, or “negative” pressure to the wound base. This therapy removes edema and chronic exudate, reduces bacterial colonization, enhances formation of new blood vessels, increases cellular proliferation, and improves wound oxygenation as the result of applied mechanical force. These actions are synergistic. Numerous applications of this modality have proven successful, including use over exposed bone, tendons, and hardware to generate granulation tissue. It is also frequently used to facilitate adherence of split thickness skin grafts, rotational flaps, or tissue substitutes to a wound bed. A recent clinical trial of the V.A.C.® device for the treatment of open amputation wounds in the diabetic foot showed significantly faster healing and development of granulation tissue with NPWT compared with standard moist wound care.
The 2004 guidelines from the Infectious Diseases Society of America (IDSA) do not make a formal recommendation for the use of wound vacuum-drainage systems. (48) However in the section, “Treatment of Infection, Adjunctive Treatments,” the following is noted: Investigators and industry representatives have advocated many types of wound-care treatments, including wound vacuum-drainage systems, recombinant growth factors, skin substitutes, antimicrobial dressings, and maggot (sterile larvae) therapy. Although each treatment likely has some appropriate indications, for infected wounds, available evidence is insufficient to recommend routine use of any of these modalities for treatment or prophylaxis. These guidelines are in the process of being updated, with publication expected in the winter of 2012.
Medicare National Coverage
In October 2000, Healthcare Financing Administration (HCFA; now Centers for Medicare and Medicaid Services, CMS) issued the following durable medical equipment regional carrier (DMERC) coverage policy, which stated that patients meeting the following criteria would be eligible for negative wound pressure therapy in the home setting:
Patient has a chronic Stage III or Stage IV pressure ulcer, venous or arterial insufficiency ulcer, or a chronic ulcer of mixed etiology. A complete wound therapy program should have been tried or considered and ruled out prior to application of negative pressure wound therapy.