Coverage Policy Manual
Policy #: 1997254
Category: DME
Initiated: July 1997
Last Review: October 2018
  Vacuum Assisted Closure Device

Description:
The Vacuum Assisted Closure  system consists of a medical-grade, open-cell polyurethane ether foam dressing that has been approved by the FDA for contact with open wounds.  The pore size ranges from 400 to 600 µm to maximize tissue growth.  An evacuation tube with side ports that communicate with the reticulated foam is embedded in the foam.  The open-cell nature of the foam ensures equal distribution of the applied subatmospheric pressure to all spaces within the system and to all surfaces in contact with the foam.  The foam dressing is cut to the specific wound geometry and placed into the wound defect with the evacuation tube exiting parallel to the skin.
 
The Vacuum Assisted Closure applies universal force to draw the edges of the wound to the center, thus assisting wound closure.  The negative pressure on the wound created by the Vacuum Assisted Closure also helps reduce edema, increase blood supply and decrease bacterial colonization.
 
The staging of pressure ulcers used in this policy is as follows:
    • Stage I - Observable pressure related alteration of intact skin whose indicators as compared to the adjacent or opposite area on the body may include changes in one or more of the following: skin temperature (warmth or coolness), tissue consistency (firm or boggy feel) and/or sensation (pain, itching). The ulcer appears as a defined area of persistent redness in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues.
    • Stage II - Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater.
    • Stage III - Full thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue.
    • Stage IV - Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.
 
A non-powered (mechanical) NPWT system has also been developed; one device is the Smart Negative Pressure (SNaP) Wound Care System. This device is portable and lightweight (3 oz) and can be worn underneath clothing. This system consists of a cartridge, dressing, and strap; the cartridge acts as the negative pressure source. The system is reported to generate negative pressure levels similar to other NPWT systems. This system is fully disposable.
 
Regulatory Status
Negative pressure therapy or suction devices cleared by the U.S. Food and Drug Administration (FDA) for the purpose of treating chronic wounds include, but are not limited to: V.A.C.® (Negative pressure therapy Assisted Closure®) Therapy™ (KCI); Versatile 1™ Wound Negative pressure therapy System (Blue Sky Medical), and RENASYS™ EZ (Smith & Nephew).
 
Portable systems include the RENASYS™ GO (Smith & Nephew), XLR8 PLUS (Genadyne
Biotechnologies), extriCARE® 2400 NPWT System (Devon Medical), the V.A.C. Via™ (KCI) and the
PICO™ Single-Use Negative Pressure Wound Therapy System (Smith & Nephew). The Prevena™
Incision Management System (KCI) is designed specifically for closed surgical incisions.
 
A nonpowered NPWT device, the SNaP® Wound Care System from Spiracur, is a class II device requiring notification to market but not having FDA premarket approval. It received 510(k) marketing clearance from FDA in 2009 (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, subacute wounds and diabetic and pressure ulcers.
 
No NPWT device has been cleared for use in infants and children.
 
In November 2009, FDA issued an alert concerning complications and deaths that had been associated with NPWT systems. An updated alert was issued in February 2011 (available
 
FDA product code: OMP.
  
Coding
There are 2 CPT codes for application of negative pressure wound therapy utilizing durable medical equipment:
 
97605: Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters
97606: total wound(s) surface area greater than 50 square centimeters
 
Effective in 2015, there are also CPT codes for application of negative pressure wound therapy utilizing disposable, non-durable equipment:
 
97607: Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters
 
97608: total wound(s) surface area greater than 50 square centimeters
 
Effective in 2012, there is a specific HCPCS code for a disposable NPWT system (such as the SNaP® system)- A9272: Mechanical wound suction, disposable, includes dressing and all accessories and components, each.
 

Policy/
Coverage:
Effective October 2018
 
The use of the powered vacuum assisted closure device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
 
Initiation of Negative Pressure Wound Therapy (NPWT):
An initial 2-week therapeutic trial using a negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered to meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following indications:
 
    • Stage III or IV Pressure Ulcers, Chronic (> 90 days)  that have failed to heal despite optimal wound care when:
 
        • there is high-volume drainage that interferes with healing and/or
        • when standard dressings cannot be maintained due to anatomic factors,
 
 
OR
 
 
    • Traumatic or Surgical wounds where:
 
        • there has been a failure of immediate or delayed primary closure AND
        • there is exposed bone, cartilage, tendon, or exposed surgically implanted material within the wound AND
        • there are no contraindications to use (see below note for list of contraindications),
 
Examples of traumatic or surgical wounds with failed or delayed closure include but are not limited to: dehisced wounds, infected sternotomy wounds and skin grafts at an anatomical site where adherence and granulation cannot be achieved with other available topical wound treatment.  
 
  
OR
  
 
    • Non-Healing (at least 30 days) Wounds that have failed to heal despite optimal wound care in patients with underlying clinical conditions which are known to negatively impact wound healing.
 
Examples of underlying conditions include, but are not limited to:
 
          • diabetes (ulcers due to neuropathy),
          • malnutrition,
          • small vessel disease (ulcers due to venous or arterial insufficiency)
          • morbid obesity.
 
 
Continuation of NPWT:
Continuation of the NPWT system, as part of a comprehensive wound care program, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes following an initial 2-week therapeutic trial or a subsequent treatment period if the treatment has resulted in documented objective improvements in the wound. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.
 
Note:  Wound healing during use of the NPWT system should be monitored on a weekly basis.
 
Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and surgically implanted material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.
 
Continuation of the NPWT system does not meet Primary Coverage Criteria for effectiveness when any of the following occur:
 
    • The therapeutic trail or subsequent treatment period has not resulted in documented objective improvement in the wound, OR
    • The wound has developed evidence of wound complications contraindicating continued NPWT, OR
    • The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.
 
Therapeutic trials of negative pressure wound therapy (NPWT) systems for the treatment of other acute or chronic wounds except as noted above does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.  For contracts without primary coverage criteria, therapeutic trials of NPWT systems for the treatment of other acute or chronic wounds except as noted above is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: Contraindications to the use of NPWT systems include the following conditions as noted by a  November 2009 FDA alert: necrotic tissue with eschar, untreated osteomyelitis, non-enteric and  unexplored fistulas, malignancy in the wound, exposed nerve, anastomotic site, or organ.
  
Non-powered and Other Negative Pressure Wound Therapy:
The use of non-powered NPWT systems (eg  the SNaP™ wound care device) for the treatment of acute or chronic wounds does not meet member benefit certificate primary coverage  criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, the use of non-powered NPWT systems (eg  the SNaP™ wound care device) for the treatment of acute or chronic wounds is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of portable, battery powered or disposable NPWT systems (eg the PICO™ single use NPWT System or the V.A.C.Via™ NPWT System) for the treatment of acute or chronic wounds does not meet member benefit certificate primary coverage  criteria that there be scientific evidence of effectiveness in improving health outcomes. . For contracts without primary coverage criteria, the use of portable, battery powered or disposable NPWT systems (eg the PICO™ single use NPWT System or the V.A.C.Via™ NPWT System) for the treatment of acute or chronic wounds is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective August 2011-September 2018
The use of the vacuum assisted closure device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
 
Initiation of Negative Pressure Wound Therapy (NPWT):
 
An initial 2-week therapeutic trial using a negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered to meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following indications:
 
    • Chronic (> 90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, or
    • Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure AND there is exposed bone, cartilage, tendon, or foreign material within the wound AND no contraindications to use are present, or
    • Wounds in patients with underlying clinical conditions which are known to negatively impact wound healing which are non-healing (at least 30 days) despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. (Malnutrition, while a risk factor, must be addressed simultaneously with the negative pressure wound therapy.)
 
Continuation of NPWT:
 
Continuation of the NPWT system, as part of a comprehensive wound care program, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes following an initial 2-week therapeutic trial or a subsequent treatment period if the treatment has resulted in documented objective improvements in the wound. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.
 
Note:  Continuation of healing during use of the NPWT system should be monitored on a frequency not  less than every 14 days.
 
Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and  foreign material were completely covered, healthy granulation were present to within 5 mm of the  surface, and the wound edges were reduced to 2 cm in width or diameter.
 
Continuation of the NPWT system does not meet Primary Coverage Criteria for effectiveness when any of the following occur:
    • The therapeutic trail or subsequent treatment period has not resulted in documented objective improvement in the wound, OR
    • The wound has developed evidence of wound complications contraindicating continued NPWT, OR
    • The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.
 
Therapeutic trials of negative pressure wound therapy (NPWT) systems for the treatment of other acute or chronic wounds except as noted above does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.  For contracts without primary coverage criteria, therapeutic trials of NPWT systems for the treatment of other acute or chronic wounds except as noted above is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: Contraindications to the use of NPWT systems include the following conditions as noted by a  November 2009 FDA alert: necrotic tissue with eschar, untreated osteomyelitis, non-enteric and  unexplored fistulas, malignancy in the wound, exposed nerve, anastomotic site, or organ.
  
Non-powered Negative Pressure Wound Therapy:
The use of non-powered negative pressure wound therapy systems for the treatment of acute or chronic wounds does not meet member benefit certificate primary coverage  criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, the use of non-powered negative pressure wound therapy systems for the treatment of acute or chronic wounds is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective May, 2010 through July 2011
 
The vacuum assisted closure device is a specific contract exclusion in most member benefit contracts.  
 
Effective May, 2010
The use of the vacuum assisted closure device, allowed as an exception to the exclusion, will be made for:
Initiation of Negative Pressure Wound Therapy (NPWT):
An initial 2-week therapeutic trial using a negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered to meet Primary Coverage Criteria in the following indications:
Chronic (> 90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, or
Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure AND there is exposed bone, cartilage, tendon, or foreign material within the wound AND no contraindications to use are present, or
Wounds in patients with underlying clinical conditions which are known to negatively impact wound healing which are non-healing (at least 30 days) despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. (Malnutrition, while a risk factor, must be addressed simultaneously with the negative pressure wound therapy.)
 
Continuation of NPWT:
Continuation of the NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial 2-week therapeutic trial or a subsequent treatment period if the treatment has resulted in documented objective improvements in the wound. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.
 
Continuation of the NPWT system does not meet Primary Coverage Criteria for effectiveness when any of the following occur:
The therapeutic trail or subsequent treatment period has not resulted in documented objective improvement in the wound, OR
The wound has developed evidence of wound complications contraindicating continued NPWT, OR
The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.
 
Therapeutic trials of negative pressure wound therapy (NPWT) systems for the treatment of other acute or chronic wounds except as noted above does not meet Primary Coverage Criteria for effectiveness.  
 
Contraindications to the use of NPWT systems include the following conditions as noted by a November 2009 FDA alert: necrotic tissue with eschar, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed nerve, anastomotic site, or organ.
 
Continuation of healing during use of the NPWT system should be monitored on a frequency not less than every 14 days.
 
Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.
 
For contracts without the specific exclusion and/or without Primary Coverage Criteria, the use of negative pressure therapy for wound treatment that is not consistent with the above-listed criteria is considered investigational and is not covered.  Investigational services are an exclusion in the member benefit certificate.
  
 
Effective prior to May, 2010
The use of the vacuum assisted closure device, allowed as an exception to the exclusion, will be made for:
diabetic patients with a non-healing wound of the foot after partial amputation;
culture positive sternal wound infections with wound dehiscence.
 
Coverage for longer than 30 days will require documentation of decreased drainage and a decrease in the size and depth of the wound.
 
For contracts without a specific exclusion, the use of the vacuum assisted closure device for any indication not listed above as covered does not meet Primary Coverage Criteria for effectiveness and is not covered.
 
For contracts without the specific exclusion and/or without Primary Coverage Criteria, the use of negative pressure therapy for wound treatment for any indication not listed above is considered investigational and is not covered.  Investigational services are an exclusion in the member benefit certificate.

Rationale:
In 2000, literature was reviewed to evaluate vacuum-assisted closure of pressure ulcers, venous ulcers, and diabetic ulcers. The observations and conclusions:
    • One randomized controlled trial was identified, which included 24 patients with a total of 36 wounds, mostly pressure ulcers. The study reported statistically significant improvements in some parameters of wound healing. However, there were significant methodologic flaws in the study. For example, partial wound closure was used as the primary outcome of interest instead of the more clinically relevant complete closure. In addition, as wounds vary pathophysiologically, stratification of wound size, duration, and location is necessary. All of these variables were reported in aggregate form, making the finding impossible to interpret.
    • Uncontrolled trials, frequently using patients as their own controls, have reported favorable results. However, due to the multimodality nature of wound care, randomized trials are necessary to isolate the individual contribution of vacuum-assisted closure to overall wound care.
 
2002 Update
A MEDLINE literature search for the period of 2001 to April 2002 did not identify any published literature that would addresses the limitations identified.  Specifically, the literature search identified a number of uncontrolled small case series in a variety of wound types, many used in the hospital setting. No controlled studies were identified.
 
2005 Update
A literature review was performed for the period of 2004 through November 2005.  Two additional randomized, controlled comparisons of negative pressure therapy in the treatment of wounds were found.  Both were considered to be of poor quality, as judged by the general approach to grading evidence developed by the U.S. Preventive Services Task Force.  In addition, neither reported on time to complete healing, considered the primary end point of this type of study.
 
Eginton et al.  included patients with diabetic foot wounds that were not expected to heal within 1 month and reported on change in wound dimensions.  Using a crossover design in 6 patients who first had 2 weeks of either moist dressings or negative pressure therapy, then switched to the other for 2 weeks, the mean change in area was an increase of 5.9% for the control intervention and a decrease of 16.4% for negative pressure therapy. The mean percent reduction in wound volume was 0.1% in the moist dressing phase and 59% in the negative pressure therapy phase (p<0.005). The following comparisons of mean percent change values for moist dressings and negative pressure therapy, respectively, were observed: +6.7 and -4.3 (length, p>0.05); +2.4 and -12.9 (width, p>0.05); and -7.7 and -49 (depth, p<0.05).
 
Moues et al. reported 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). The authors also found a significantly higher daily percent change in wound area among negative pressure therapy patients (3.8), compared with conventionally treated patients (1.7, p<0.05).
 
A 2004 systematic review published by the Agency for Healthcare Research and Quality (Sampson) concluded that trials published thus far “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”.
 
Shirakawa and Isseroff (2005) concluded that current reports have not proven that wound healing is substantially better with the device than with traditional therapy and that large multicenter, randomized, controlled trials are needed.
 
Trial protocols provided by the manufacturer of the V.A.C.® device (Kinetic Concepts, Inc., KCI) outlined much larger trials that are condition-specific and address many of the quality problems found in the published studies. If implemented and completed successfully as planned, these trials will provide substantial advances in the evidence base for negative pressure therapy, and may allow more definitive conclusions on the efficacy of negative pressure therapy.
 
In Nov 2005 results of a study (NCT00224796) by Armstrong et al. was published.  162 patients were enrolled in a 16-week, 18-centre, randomized clinical trial in the USA.  Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion.  Patients who were randomly assigned to negative pressure wound therapy (NPWT) (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines.  Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat.
 
More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0·040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0·005).  The rate of granulation tissue formation, based on the time to 76–100% formation in the wound bed, was faster in the NPWT group than in controls (p=0·002). The frequency and severity of adverse events (the most common was wound infection) were similar in both treatment groups.
 
2008 Update
Braakenburg and colleagues, 2006, 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 were defined as acute (< 48 hours old), subacute (<6 weeks), or chronic (>6 weeks). The primary outcome, wound-healing time, was calculated from the date of initial debridement at study entry to the date of reaching an endpoint, defined as a complete granulated wound, or a wound ready for skin grafting or healing by secondary intention. Twenty-six (81%) NPWT patients and 19 (58%) conventional therapy patients reached an endpoint (chi-square =4.27, 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. NPWT did not significantly reduce bacterial load, enhance wound granulation, or increase the rate of wound closure compared with conventional care. Substantial, unaccounted loss to follow-up (NPWT, 19%; controls, 36%) and ill-defined wound characteristics confound the results.
 
Vuerstaek and colleagues, 2006. compared the efficacy of NPWT using the V.A.C.® system (n=30) with conventional care (n=30) in patients hospitalized with chronic venous, combined venous and arterial, or microangiopathic (arteriolosclerotic) leg ulcers (ABI>0.60) of greater than 6 months duration after failure of ambulatory (>6 months) or surgical options in an outpatient clinic according to the Scottish Intercollegiate Guideline Network (SIGN). Following complete debridement, patients were randomly allocated to NPWT or conventional moist wound care until granulation tissue covered 100% of the surface. Full-thickness punch skin grafts from the thigh were applied, followed by 4 days of 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 (95% CI: 25.5–32.5) with NPWT and 45 days (95% CI: 36.2–53.8) 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. A slightly greater number of adverse events occurred in the NPWT group (12 total) than in the controls (7 total), primarily due to cutaneous damage secondary to therapy (7 vs. 2, respectively). Ulcer relapse occurred in 52% (n=10) of NPWT patients compared with 42% (n=10) of controls (p=0.47). A total of 11 patients (18%) dropped out before follow-up was complete, but intention-to-treat analysis accounted for this. 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.
In 2008 an update of a 2002 Cochrane review of negative pressure wound therapy for treatment of chronic wounds was published (Ubbink).  Five RCTs were reviewed in this second update for a total of 7 trials involving 205 participants. The 7 trials compared NPWT with 5 different comparator treatments; 4 trials compared NPWT with gauze soaked in either 0.9% saline or Ringer's solution. The other 3 trials compared NPWT with hydrocolloid gel plus gauze, a treatment package comprising papain-urea topical treatment, and cadexomer iodine or hydrocolloid, hydrogels, alginate and foam. The authors report 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 methodological flaws and data do demonstrate a beneficial effect of NPWT on wound healing however more, better quality research is needed.” 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 methodological quality of the trial was poor (Wasiak).  The authors concluded that there is a “paucity of high quality RCTs 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.” Authors of other systematic reviews, even if they conclude that there is evidence of efficacy, call for larger, high quality studies. (Vikatmaa, 2008; Noble-Bell, 2008))
 
Of the RCTs identified in the most-recent literature search, one compared negative pressure wound therapy with advanced moist wound therapy (predominantly hydrogels and alginates) and was not considered in this update. The second was a post hoc retrospective study of resource utilization and costs in a study reviewed in a previous update (Armstrong, 2005). The third describes a RCT of NPWT carried out in India using a locally constructed device (Mody, 2008).  In this study, 48 patients were randomized to NPWT or moist dressings. Wounds etiologies were diabetic foot ulcers (n=15), pressure ulcers (n=11), cellulitis/fasciitis (n=11), and “other” (n=11). 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]). NPWT-managed wounds in patients who remained hospitalized closed faster than gauze-dressed wounds. The high drop-out rate prevents drawing clear conclusions from this study.
 
Interest in the use of this modality for management of surgical and traumatic wounds is reflected in the large number of articles reporting on these applications in the recent literature. Three non-randomized comparative studies were identified in the literature search. (A preliminary report of 2 RCTs evaluating NPWT to treat hematomas and surgical incisions following high-energy trauma was published in 2006 (Stannard), however no report of the completed study was found.)  Shilt et al. (2004) compared outcomes for 16 children treated with NPWT after lawnmower injuries to outcomes for 15 historic controls treated with wet-dry or Xeroform dressings.  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 comparable control group. Yang and colleagues (2006) 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).  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. (2009) retrospectively reviewed records of patients with upper (UE) and lower extremity (LE) fasciotomy wounds treated over a 10-year period.  Some wounds were treated exclusively with NPWT, some with only normal saline wet-to-dry dressings, and some with both according to surgeon preference. Of 142 UE wounds, 74 received conventional treatment and 68 were treated with NPWT. Of 662 LE 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 (P<0.05) for all lower extremity wounds (this appears to include wounds treated with the combination of NPWT and wet-to-dry dressings), and 55.6% (P<0.03) for upper extremity wounds. Lack of an equivalent contemporaneous control group limits the application of these findings.
 
A large number of case series are reported. Two papers describe case series of patients treated with NPWT after deep wound infections following spinal fusion (Van Rhee, 2007).  A prospective study of 6 children reported that infection (all caused by Staphylococcus aureus, one of them methicillin resistant and one in which Enterobacter cloacae also cultured) was controlled in all children and removal of instrumentation was not required in any. Time to wound closure averaged 3 months. Ploumis et al.(2006) retrospectively reviewed 73 patients who had 79 wound infections after undergoing spine surgery. Sixty patients had implants (instrumentation or allograft) within the site of wound infection, and 6 had recurrent infections. Once NPWT was initiated, there was an average of 1.4 procedures until and including closure of the wound. The wound closed an average of 7 days (range, 5-14) after placement of the NPWT device. At minimum follow-up of one year, all but 2 achieved a clean, closed wound without removal of instrumentation. Only culture of methicillin-resistant Staphylococcus aureus or multiple bacteria appeared to be related to repeat NPWT procedures. The authors conclude that NPWT “may be an effective adjunct in closing spinal wounds even after the repeat procedures.” Data from case series must be interpreted with great caution.
 
Svensson and colleagues (2008) retrospectively reviewed records of 33 patients who had NPWT of perivascular surgical site infections in the groin after arterial surgery between August 2004 and December 2006. Median duration of NPWT was 20 days and 27 wounds (82%) healed within 55 days.  One serious NPWT-associated bleeding and 3 late false femoral artery aneurysms were reported. Synthetic vascular graft infection (n=20) was associated with adverse infection-related events.
 
An article that systematically reviewed the evidence was published in 2008 by Gregor and colleagues.  The authors noted that although there is some indication that NPWT may improve wound healing, the body of evidence is insufficient to clearly prove and additional clinical benefit of NPWT. They also noted that the large number of prematurely terminated and unpublished trials are reason for concern.
 
 
2010 Update
An Agency for Healthcare Research and Quality (AHRQ) technology assessment was performed for the Centers for Medicare and Medicaid Services (CMS) and is posted on the AHRQ website. (Negative Pressure Wound Therapy Devices. Technology Assessment Report. Project ID: WNDT1108. May 26, 2009)
 
This technology assessment of negative pressure wound therapy devices was looking primarily for “therapeutic distinctions” between the various negative pressure wound therapy 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 was performed by ECRI Institute and 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 study by Peinemann (2008) as follows: In their systematic review of clinical studies of NPWT, Peinemann et al. sought to identify unpublished completed or discontinued 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 RCTs and only provided case reports. The authors determined that of 28 RCTs, 13 had been completed, six had been discontinued, six were ongoing, and the status of three 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.”
 
Chio and Agrawal, 2010, recently published results of a randomized trial of 54 patients comparing a negative pressure dressing with a static pressure dressing.  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.
 
Summary
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 for acute and chronic wounds with either demonstrated failure to heal despite intense conventional wound therapy for 90 days or more, or for those 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.
 
STERNAL WOUND INFECTIONS
The vacuum assisted closure device for the treatment of infected sternal wounds after cardiac surgery has been reported for small numbers of hospital inpatients.  There is little published information in medical literature about the home use of this device that also requires home health nursing visits.  
 
Harsh (2001) reported on 15 patients where vacuum-assisted closure was used as a bridge to closure after debridement when culture of healthy appearing bone was less than 105 CFU/g tissue.  When cultures indicated resolution of the local infection the wound was closed primarily or using regional muscle flap.
 
Doss (2002) retrospectively looked at 42  patients with post sternotomy osteomyelitis, 20 treated with vacuum-assisted suction drainage (VASD), 22 with conventional wound management.  VASD patients, compared to the conventional therapy group, had reduced treatment duration (mean 17.2 +/- 5.8 vs 22.9 +/- 10.8 days, P = 0.009) and total hospital days (mean 27.2 +/- 6.5 vs 33.0 +/- 11.0 days, P = 0.03). "The formation of granulation tissue that ultimately leads to secondary wound healing showed an average of 2.3 cm2/d (range 2.7-3.6) reduction in wound size in the conventional group and 4.63 cm2/d (range 2.9-6.5) in the VASD group."
 
Fleck (2002) reported 11 patient with sternal wound infection who had placement of the VAC system after initial surgical debridement.  The system was removed after mean of 9.3 days (range 4-15) when quantitative cultures were negative and there were no systemic signs of infection.  Primary wound closure was achieved in 5 patients and the device served as a bridge to reconstructive surgery in 6 patients.
 
Song et al., in 2003, reported a retrospective review of 35 consecutive patients with vacuum assisted closure (VAC) used as a bridge between debridement and definitive closure.  Eighteen patients (before VAC available) were treated with dressing change BID, 17 with VAC.  the BID dressing group had mean of 8 +/- 2.9 days between initial debridement and definitive closure while the mean for the VAC group was 6 +/- 1.3 days.  The BID dressing group required 25 flaps to close 17 sternal wounds while the VAC group required 13 flaps to cover 14 sternal wounds.
 
Cowan (2005) reported a retrospective study of 22 patients treated with VAC for post-cardiac surgery wound complications which became evident on average at 21 days after surgery.  Irrigation and debridement were performed and VAC placed approximately 7.3 days after diagnosis.  Progressive, rapid improvement in wound size was noted over the course of VAC.  Eight patients received direct closure, six were allowed to completely granulate in, closing by secondary intention.  The remaining eight patients who had no dramatic improvement with VAC received additional debridement and surgical reconstruction using a regional flap.
 
Bapat et al, 2008, noted that patients who received VAC for a prolonged duration so as to allow the wound to heal secondarily often had recurrent sternal wound problems requiring additional surgical procedures such as wound debridement, sternal wire removal, or sinus excision.  The authors suggest limiting the duration of VAC therapy and attempt surgical closure of the wound at the first opportunity unless prevented by the general condition of the patient.
 
2010 Update
A number of reports of NPWT in the management of sternotomy wounds, most small case series from outside the US and some that included little data with respect to clinical outcomes including time to healing, have been identified.  Tocco and colleagues (2009) report on 21 patients with mediastinitis after sternotomy all of whom were treated with NPWT for an average of 26 days (range, 14-37). Once wound tissue appeared viable and cultures were negative, the chest was closed; in 9 cases using pectoralis flaps, in 9 using Nitinol clips, in one with a combination of muscle flap and Nitinol clips, and in one with sternal wires. Canadian researchers studied predictors of failure of NPWT closure of sternotomy wounds (Gdalevitch, 2010).  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.
 
2011 Update
A search of the MEDLINE database through February 2011 found a systematic review, as well as case series, retrospective comparative studies, and concurrent comparative studies (generally not randomized); most studies were from non-US centers. Xie and colleagues identified 17 RCTs of NPWT that met their criteria for systematic review and found consistent evidence of benefit compared with control treatments for diabetic foot ulcers and conflicting evidence for pressure ulcers (Xie, 2010).   In trials involving mixed wounds, evidence was encouraging, but the trials were of inadequate quality. An expert panel convened to develop evidence-based recommendations for the use of NPWT reported that the present evidence base is strongest for the use of NPWT on skin grafts and weakest as a primary treatment for burns (Runkel, 2011).   An analysis of NPWT for patients with infected sternal wounds concluded, based on 6 articles and 321 patients, that NPWT resulted in a decrease of 7.2 days in hospital length of stay with no significant impact on mortality (Damiani, 2011).
 
Two recent papers report identifying groups 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 (Schmelzle, 2010).  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 retrospective multicenter study of hospitalized patients with spinal cord injuries and stage III/IV pelvic pressure ulcers treated with standard wound care (n=53) or NPWT (n=33) measured wound surface over a 28-day observation period (Ho, 2010).   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. Over the 28-day period, serum albumin concentrations were significantly improved in the healing groups whether or not treated with NPWT. The authors noted that “NPWT may have partially contributed to the lower (or to maintaining the lower) serum albumin concentrations in persons who have malnutrition and a reduced ability to compensate for the wound-related protein loss.”
 
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 (Ugaki, 2010).   A U.S. center reported using gauze-based NPWT after skin grafting in an infant burn patient (Psoinos, 2009).  
 
Non-powered 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.
 
Armstrong and others report 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 (Armstrong, 2011).   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 (p<0.05). 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. At the start of treatment, wounds in the VAC group were larger (VAC 8.8 + 9.7 cm2 vs. SNaP 4.3 + 4.1 cm2) and of longer duration (13.7 months vs. 8.3 months than wounds in the SNaP group). This study does not provide comparison with standard treatment protocols. The authors emphasize that the wounds treated in this study were predominantly secondary to venous disease and therefore were generally more superficial.
 
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 (Lerman, 2010).  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 and were considered treatment failures. Eighteen of the remaining 21 patients treated with the SNaP device demonstrated a statistically significant healing trend (p<0.05). Between-group estimates of time-to-wound healing by Kaplan-Meier analysis were statistically significantly in favor of the SNaP treatment group. Multiple modalities were used in treatment of historical controls. The authors acknowledge that the large number of dropouts and the limitations of retrospectively controlled studies and note 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 possibly resulting in more frequent debridement in the experimental group.
 
Other publications have described use of the SNaP device in case series with small numbers of patients, fewer than 15 patients (Fong, 2010) (Lerman, 2010) (Landsman, 2010). Landsman comments that by removing compliance barriers, this device may encourage more frequent use of NPWT for small wounds (Landsman, 2010).
 
Summary
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 at least 14 days meets primary coverage criteria for acute and chronic wounds with either demonstrated failure to heal despite intense conventional wound therapy for 90 days or more, or for those 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.
 
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, the coverage statement is amended to include a statement that non-powered devices do not meet primary coverage criteria.
 
2014 Update
A literature search was conducted using the MEDLINE database through February 2014. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
Diabetic Lower-Extremity Ulcers
A 2013 Cochrane review of NPWT for treating foot wounds in patients with diabetes mellitus included 5 randomized trials with a total of 605 participants (Dumville, 2013). Two of the 5 studies had a total of 502 participants, the remaining 3 were small, with limited reporting, and with an unclear risk of bias. One of the larger studies (described next) was conducted in patients with diabetic foot ulcers, and the second was in patients with postamputation wounds. Both studies showed a benefit of NPWT, but were considered to be at risk of performance bias due to lack of blinding.
 
Burn Wounds
A 2012 Cochrane review identified 1 RCT of NPWT that met the inclusion criteria (Dumville, 2012). The trial had poor reporting with an absence of data and was considered to be at high risk of bias. No conclusions could be drawn at that time regarding the use of NPWT for this indication.
 
In 2012, Bloemen et al reported a multicenter 4-armed randomized trial with 86 patients that compared a split-skin graft with or without a dermal substitute (Matriderm), with or without NPWT (Bloemen, 2012). Outcome measures included graft take at 4 to 7 days after surgery, rate of wound epithelialization, and scar parameters at 3 and 12 months postoperatively. Graft take and wound epithelialization did not differ significantly between the groups. Most measures of scar quality also did not differ significantly between the groups.
 
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Mixed Wound Type
 
Systematic Reviews
In 2014, authors of systematic review from the Johns Hopkins University Evidence-based Practice Center for AHRQ and the Centers for Medicare and Medicaid Services (CMS) reported that due to insufficient evidence, they were unable to draw conclusions about the efficacy or safety of NPWT in the home setting (Rhee, 2014).
 
Randomized Trials
Biter et al (2014) found no significant advantage of 2 weeks of NPWT in a study of 49 patients who underwent surgical excision for pilonidal sinus disease (Biter, 2014). Complete wound healing was achieved at a median of 84 days in the NPWT group and 93 days in controls.
 
Practice Guidelines and Position Statements
2012 guidelines from IDSA for the diagnosis and treatment of diabetic foot infections state that no adjunctive therapy has been proven to improve resolution of infection, but for selected diabetic foot wounds that are slow to heal, clinicians might consider using negative wound therapy (weak recommendation, low quality evidence) (Lipsky. 2014).
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
NPWT devices can be classified as either powered, ie, requiring an electrical power source, or mechanical. Most evidence is for electrically powered devices with large canisters such as the V.AC. and the main discussion of evidence refers to this type of device. A number of portable devices have entered the market, and are particularly relevant for use in the outpatient setting. Some portable devices are mechanically powered while others are designed specifically for surgical incisions. Evidence on the newer portable devices is discussed separately following the review of evidence on the larger electrically powered devices.
 
Mixed Wound Types
Systematic Reviews
Particularly relevant for this evidence review is the effect of NPWT when used in the home setting. In 2014, authors of a systematic review from the Johns Hopkins University Evidence-based Practice Center for Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS) reported that due to insufficient evidence, they were unable to draw conclusions about the efficacy or safety of NPWT in the home setting. These authors found the available data was limited by variability in the types of comparator groups, methodological limitations, and poor reporting of outcomes (Rhee, 2015).
 
Pressure Ulcers
A 2015 Cochrane review included 4 RCTs (N=149) of NPWT for treating pressure ulcers in any care setting, although most of the patients were treated in a hospital setting (Dumville, Webster, 2015). Three studies were considered to be at high risk of bias and all evidence was considered to be of very low quality. Only 1 study reported on complete wound healing, which occurred in only 1 of the 12 participants in the study. The review concluded that there is high uncertainty about the potential benefits or harms for this indication.
 
Diabetic Lower-Extremity Ulcers and Amputation Wounds
Dalla Paola and colleagues also reported more rapid development of granulation tissue, more rapid control of infections, and reduced time to complete closure (65 days vs 98 days) in patients with infected open minor amputations (Dalla, 2010). Interpretation of this study is limited, as the size and chronicity of wounds prior to treatment were not recorded, and the assessments were nonblinded.
 
Lower-Extremity Ulcers Due to Venous Insufficiency
A 2015 Cochrane review identified a single RCT with 60 patients (Dumbille, Lands, 2015). This study (described next) was performed in an inpatient setting in conjunction with skin grafts. The 2015 Cochrane review did not identify any RCT evidence on the effectiveness of NPWT as a primary treatment for leg ulcers nor any evidence on the home use of NPWT.
 
Burn Wounds
A 2014 Cochrane review identified 1 interim report (abstract) of an RCT on NPWT in patients with partial thickness burns. (Dumviulle, Munson, 2014). There was not enough evidence to permit any conclusions regarding the efficacy of NPWT on partial thickness burn wounds.
 
Not included in the Cochrane review was a 2012 study by Bloemen and colleagues on the effect of NPWT on graft take in full thickness burn wounds (Bloemen, 2012).
 
Traumatic and Surgical Wounds
Identified studies describe a variety of wound types treated over periods ranging from several days to several months. Studies also differ in whether NPWT was used for nonhealing wounds or as a prophylactic treatment for surgical wounds in patients at high risk for nonhealing.
 
A 2014 Cochrane review evaluated the evidence on NPWT for skin grafts and surgical wounds expected to heal by primary intention (Webster, 2014). Healing by primary intention occurs when the wound edges are brought together with sutures, staples, tape, or glue, and contrasts with healing by secondary intention, where the wound is left open to heal from the bottom up (eg, for chronic or infected wounds). Nine randomized trials with a total of 785 patients were included in the review. Three trials involved skin grafts, 4 included orthopedic patients, and 2 included general surgery and trauma surgery patients. All of the trials had unclear or high risk of bias. There were no differences between standard dressing and NPWT in surgical site infections, wound dehiscence, reoperation (in incisional wounds), seroma/hematoma, or failed skin grafts. Pain intensity was reported to be lower with “home-made” NPWT compared with commercial devices. Most or all studies appear to have used short-term application of NPWT in an inpatient setting.
 
A 2015 Cochrane review evaluated the evidence on surgical wounds healing by secondary intention in any care setting (Dumville, Owens, 2015).  Two studies (total N=69 patients) were identified for the review. Both studies reported a reduction in the median time to healing with NPWT, but there were limited outcome data on the number of wounds healed, adverse events, and resource use. The authors concluded that there is currently no rigorous RCT evidence available regarding the clinical effectiveness of NPWT in the treatment of wounds healing by secondary intention.
 
A small RCT (N=20) of NPWT in an outpatient setting suggests that NPWT may impact the number of dressing changes, reduce pain, and improve quality of life compared to standard wound care (Monsen, 2015). Additional study in a larger number of patients is needed to evaluate these outcomes.
 
Portable Single-Use NPWT Devices
Subgroup analysis of 40 patients with venous leg ulcers who completed the study showed a significant improvement in the percentage of patients with complete wound closure with SNaP compared to the VAC system (57.9% vs 38.2%, p=0.008). (Marsten 2015).  This study is limited by high loss to follow-up and lack of comparison with standard treatment protocols.
 
PICO Dressing
PICO is a portable single-use NPWT system that comes with 2 sterile dressings and has a life-span of 7 days. In 2015, Schwartz and colleagues reported an industry-funded pilot study with 12 patients who had small wounds of various types (Schwartz, 2015).  A key inclusion criterion was complete failure to progress over the previous 4 weeks. During the 4 weeks of PICO application, wound size decreased and wound appearance improved. There was no control group in this pilot study and no wound closures during the short follow-up period. The authors noted that in unpublished data, the device was not effective on skin graft donor sites. Additional study is needed.
 
Prevena System
Prevena is a single-use NPWT system designed specifically for incisions. In 2013, Grauhan and colleagues reported a pseudo-randomized trial (alternating assignment) with 150 consecutive obese patients who underwent cardiac surgery via a median sternotomy (Grauhan, 2013). Use of the Prevena system for 6 to 7 days beginning immediately after suturing led to a reduction in wound infections (4% vs 16%, p=0.027). Gram-positive skin flora were found in 1 patient in the Prevena group and 10 patients in the standard wound care group. This positive study was performed in an inpatient setting. A randomized trial in a larger number of patients with sternal midline incisions is scheduled to be completed in 2016.
 
n 2014, Pauser and colleagues reported a small RCT (N=21) of Prevena in patients who had undergone hemiarthroplasty for femoral neck fractures (Pauser, 2014). Use of the Prevena system resulted in a significant reduction of seroma size, days of wound secretion, wound care time, and need for dressing changes. Larger RCTs are needed to assess these outcomes.
 
A 2015 NICE Clinical Guideline on diabetic foot problems recommends consideration of NPWT after surgical débridement for diabetic foot ulcers on the advice of the multidisciplinary foot care service (NICE, 2015). It was noted that the evidence reviewed for NPWT was limited and of low quality, and that it would be useful to have more evidence for this commonly used treatment.
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2016 systematic review and meta-analysis by De Vries and colleagues included 6 RCTs and 15 observational studies of surgical site infections after prophylactic NPWT (De Vries, 2016). One study selected used a portable device (PICO, described below), while the others used a V.A.C. Unlike the 2014 Cochrane review, studies on skin grafts were not included. Meta-analysis of the RCTs showed that use of NPWT reduced the rate of surgical site infections (odds ratio, 0.56; 95% CI, 0.32 to 0.96; p=0.04), and reduced the surgical site infection rate from 140 to 83 per 1000 patients. However, the quality of evidence was rated as low due to high risk of bias in the non-blinded assessments and imprecision in the estimates.
 
PICO is a portable single-use NPWT system that comes with 2 sterile dressings and has a lifespan of 7 days. In 2016, Karlakki and colleagues reported an RCT with 220 patients that evaluated use of the PICO device in the surgical center immediately after hip and knee arthroplasties (Karlakki, 2016). The device was left on for 7 days, including time after the hospital stay. Strengths of the study included power and ITT analysis, but evaluators were not blinded. There were trends toward reductions in hospital length of stay (0.9 days; 95% CI, -0.2 to 2.5 days; p=0.07) and postoperative surgical wound complications (8.4% control vs 2.0% PICO, p=0.06). Most of the difference in length of stay was due to wound complications in 2 outliers in the control group (up to 61 days). The level of wound exudate was significantly reduced by the PICO device (p=0.007), with 4% of the study group and 16% of the control group having grade 4 (scale grade, 0-4) exudate. Blisters were observed in 11% of patients treated with the PICO system, although the occurrence of blisters was reported to be reduced when the dressing was stretched less.
 
February 2018 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2017 retrospective case series by Ehrl et al examined outcomes for 51 patients treated for burned hands with topical negative pressure wound (TNPW) therapy at a single center; of the initial 51 patients, only 30 patients (47 hands) completed follow-up, which was conducted an average of 35 months after injury and included physical examination (Ehrl, 2017). Before TNPW therapy, patients received escharotomy or superficial débridement if needed, or split-thickness skin grafts for third-degree burns and the TNPW gloves used allowed caregivers to assess patients’ fingertips for perfusion. Ergotherapy was initiated following evidence of epithelialization. Primary end points were a dorsal extension of the fingers and capability of complete active fist closure, with the majority of patients achieving one or both outcomes: the first end point was reached in 85.1% (n=40) of the cases; the second end point was reached in 78.7% of hands (n=37). When evaluated using the Disabilities of the Arm, Shoulder, and Hand questionnaire (scoring range, 0-100; with 0=no disability), patients with injuries resulting in hypertrophic scarring had significantly worse scores (28.8) than patients without similar scarring (11.7; p<0.05). Despite a number of limitations, including heterogeneity of burned areas (2.5% to 70% throughout the series), the authors acknowledged TNPW therapy as standard treatment at the institution from which these data were drawn.
 
Danne et al published a retrospective study comparing NPWT with alginate-based or gauze daily dressing in 2017, using data from 73 patients who were treated between 2006 and 2015 for natal cleft pilonidal sinus (Danne, 2017). Most patients (n=62) were assigned open healing following surgery, and 9 patients with wounds smaller than 1 cm had primary closure. The primary outcomes of interest were time to healing and, where applicable, failure to heal. For the former, patients in the daily dressing group took a median of 10 weeks (95% CI, 7 to 17 weeks) to heal, compared with 8 weeks (95% CI, 7 to 9 weeks) in the NPWT group. This difference (p=0.116) was not statistically significant, as was the difference between groups for recurrence of the pilonidal sinus (12.5% of the daily dressing group vs 3.1% of the NPWT group had disease recurrence, p=0.355); however, investigators noted that both outcomes were favorable for the NPWT group. In subgroup analysis of patients with comorbidities vs those without, there was a significantly improved likelihood of healing for the latter; given the presence of comorbidities such as previous pilonidal sinus surgery, infective skin conditions, morbid obesity, or type 1 diabetes, patients with such risks had a hazard ratio of 13.10 (95% CI, 3.90 to 44.04) compared with those free of comorbidities (p<0.001). While a number of patients were lost to follow-up, of those at the final analysis, 72.4% in the daily dressing group reached epithelialization, compared with 93.6% in the NPWT group, prompting investigators to call for larger prospective studies of the intervention.
 
O’Leary et al published an RCT in 2017 that allocated 50 patients to standard wound dressing or negative pressure wound dressing after abdominal surgery; patients had class I, II, or II wounds, and the treatment group was given the PICO dressing (O’Leary, 2017).Surgical site infection was evaluated at 4 and 30 days following surgery, and results were analyzed both on per-protocol and intention-to-treat bases. Caregivers did not find a significant difference between groups after 4 days (p=0.516); however, at 30-day follow-up, rates of surgical site infections were significantly lower for the group receiving negative pressure dressing than for the control group, both in per-protocol analysis (8.3% vs 32.0%, p=0.043) and intention-to-treat analysis (12% vs 32%, p=0.073). Univariate analysis showed a significant association between standard wound dressing and the likelihood of a surgical site infection (p=0.040); for secondary outcomes (eg, cosmetic outcome, patient satisfaction), the authors reported no difference between groups. The mean length of stay was shorter for patients who received negative pressure dressings (6.1 days) than for control patients; however, when all reasons for delayed discharge were accounted for, the difference was not statistically significant (p=0.89). While comparatively small, this trial would indicate that negative pressure dressings resulted in a beneficial outcome for patients recovering from abdominal surgery regarding the occurrence of surgical site infections.
 
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
 
International Multidisciplinary Consensus Recommendations
In 2017, Willy et al presented evidence-based consensus guidelines on the use of closed incision negative pressure therapy (ciNPT) following surgery (Willy, 2017). Among the studies found were 100 randomized controlled studies on ciNPT, most of which found an association between the use of ciNPT and improved outcomes. Based on the evidence, the consensus panel recommended that surgeons evaluate risk in patients before surgery to determine whether patient comorbidities (ie, obesity or diabetes) or the nature of the surgery presents an increased danger of infection. In such cases, the panel recommended the use of ciNPT.
 
September 2018 Update
Baillot et al (2010) conducted a study to examine the outcome of patients with deep sternal wound infection (DSWI) treated with vacuum-assisted closure (VAC) therapy as a bridge to sternal osteosynthesis with horizontal titanium plate fixation. The researchers conducted a 15-year review of 23,499 sternotomies from open heart surgery (OHS) from 1992-2007.  There were 2 periods of study. The first period of study was from 1992-2001 (N=118 DSWI) treated with conventional wound modalities of debridement/drainage with primary closure or debridement/drainage, open packing, and pectoralis skin flap closure.  The second period of study was from 2002-2007 (N=149 DSWI) treated with conventional treatment (N=24) and VAC therapy (N=125/83.8%). VAC was followed by sternal osteosynthesis with horizontal titanium plates in 92 patients (61.7%). Most patients treated with VAC therapy in our second group showed increased short-term survival and decreased perioperative mortality (freedom from all-cause mortality at 1, 5 and 10 years to be, respectively, 91.8%, 80.4% and 61.3% compared with 94.0%, 85.5% and 70.2%, respectively, for patients submitted to OHS without DSWI (p=0.01). O’Connor et al (2014) performed a retrospective review of trauma registry data from the University of Maryland School of Medicine from 2000 to 2003 with similar outcomes using vacuum-assisted closure for the treatment of complex chest wounds.  The authors concluded that the VAC system is a simple, useful, and novel alternative to conventional wound care even with large, infected wounds.

CPT/HCPCS:
97605Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters
97606Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters
97607Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters
97608Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters
A6550Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories
A7000Canister, disposable, used with suction pump, each
A7001Canister, nondisposable, used with suction pump, each
A9272Wound suction, disposable, includes dressing, all accessories and components, any type, each
E2402Negative pressure wound therapy electrical pump, stationary or portable
K0743Suction pump, home model, portable, for use on wounds
K0744Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 sq in or less
K0745Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 sq in but less than or equal to 48 sq in
K0746Absorptive wound dressing for use with suction pump, home model, portable, pad size greater than 48 sq in

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