| Coverage Policy Manual | |
| Policy #: | 1997254 |
| Category: | DME |
| Initiated: | July 1997 |
| Last Review: | February 2024 |
|
|
|
|||||||||||
| Vacuum Assisted Closure Device | |
|
|
|
| Description: |
The management and treatment of chronic wounds, including decubitus ulcers, is challenging. Most chronic wounds will heal only if the underlying cause (i.e., venous stasis, pressure, infection) is addressed. Also, cleaning the wound to remove nonviable tissue, microorganisms, and foreign bodies is essential to create optimal conditions for either re-epithelialization (i.e., healing by secondary intention) or preparation for wound closure with skin grafts or flaps (i.e., healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.
The staging of pressure ulcers used in this policy is as follows:
Negative pressure wound therapy (NPWT) involves the use of a negative pressure therapy or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue. The devices may also be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient. Although the exact mechanism has not been elucidated, it is hypothesized that negative pressure contributes to wound healing by removing excess interstitial fluid, increasing the vascularity of the wound, reducing edema, and/or creating beneficial mechanical forces that lead to cell growth and expansion.
A non-powered (mechanical) NPWT system has also been developed; the Smart Negative Pressure (SNaP) Wound Care System 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); RENASYS™ EZ (Smith & Nephew); Foryou NPWT NP32 Device (Foryou Medical Electronics), SVED® (Cardinal Health); and PICO Single Use Negative Pressure Wound Therapy System (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), NPWT PRO to GO (Cardinal Health), 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 (Spiracur, aquired by Acelity in 2015), 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.
NPWT devices with instillation include the V.A.C. VERAFLO™ Therapy device (KCI/Acelity). It was cleared for marketing in 2011 by the FDA through the 510(k) pathway (K103156) and is designed to allow for controlled delivery and drainage of topical antiseptic and antimicrobial wound treatment solutions and suspensions. It is to be used with the V.A.C. Ulta unit, which is commercially marketed for use in the hospital setting. Instillation is also available with Simultaneous Irrigation™ Technology tubing sets (Cardinal Health) for use with Cardinal Health SVED® and PRO NPWT devices, however, its use is not indicated for use in a home care setting (K161418).
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 February 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
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., meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indications:
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.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Continuation of the NPWT system does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when any of the following occur:
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 member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with 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.
Single-Use Negative Pressure Wound Therapy:
Single-use NPWT systems (powered or nonpowered) for the treatment of acute or chronic wounds do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, single-use NPWT systems (powered or nonpowered) for the treatment of acute or chronic wounds are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to February 2021
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:
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.
Continuation of the NPWT system does not meet Primary Coverage Criteria for effectiveness when any of the following occur:
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:
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:
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: |
Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com.
In 2000, literature was reviewed to evaluate vacuum-assisted closure of pressure ulcers, venous ulcers, and diabetic ulcers. The observations and conclusions:
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.
In 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.
2019 Update
A literature search was conducted through September 2019. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Borys et al conducted a prospective observational study to assess the short-term efficacy, safety, and long-term outcomes of NPWT in treating diabetic foot ulcers (Borys, 2018). Researchers assigned 75 patients to NPWT (n=53) or standard care (n=22) based on wound size. Analysis after one-year follow-up showed similar results for both groups, leading researchers to conclude NPWT is a safe alternative to but not necessarily more efficacious than the current standard of care. Limitations include small sample size, the observational design, and nonconsideration of risk factors other than wound size.
Mir et al performed a systematic review with meta-analysis to evaluate the utility of NPWT on head and neck wounds (Mir, 2018). Researchers searched five databases and found 57 articles with a pooled patient sample of 522 for inclusion in the study. The analysis determined that, across all studies, 85.7% of patients overall responded to NPWT (95% CI: 80.6%-89.6%; p<0.001). The review is limited because all included studies were observational in nature and had a small pooled sample size relative to the number of studies.
Javed et al conducted a single-site RCT to evaluate the efficacy of NPWT for surgical site infection after an open pancreaticoduodenectomy (Javed, 2018). Researchers randomized 123 patients treated from January 2017 through February 2018 to either NPWT (n=62) or standard closure (n=61). In the study, 9.7% of patients who received NPWT developed a postoperative infection at the site, compared with 31.1% of patients who received standard closure, a relative risk of 0.31 (95% CI: 0.13-0.73; p=0.003). Limitations of the study included being conducted at a high-volume treatment center and a lack of blinding.
Sahebally et al performed a systematic review with meta-analysis to evaluate the effects of NPWT on surgical site infections in closed laparotomy incisions (Sahebally, 2018). Researchers searched four databases through December 31, 2017, and screened bibliographies of retrieved studies to find further studies; nine unique studies (3 RCTs, 2 prospective studies, and 4 retrospective studies) representing 1266 unique patients were included in the review. The analysis determined that NPWT was associated with a significantly lower rate of surgical site infection compared with standard wound dressing (pooled odds ratio: 0.25; 95% CI: 0.12-0.52; p<0.001). The review was limited by including mostly non-randomized studies and use of different NPWT devices.
Tanaydin et al conducted an RCT to compare NPWT to standard wound care after a bilateral breast reduction mammoplasty (Tanaydin, 2018). In the study, 32 patients were given NPWT on one breast and fixation strips on the other, simultaneously serving as study group and control group. Sites treated with NPWT showed a significantly lower rate of complications (p<0.004) compared to fixation strips, as well as improved pain and scarring. Limitations included the small sample size and lack of blinding.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2019 Cochrane review update evaluated NPWT compared with standard dressings for surgical wound healing by primary closure. Thirty RCTs were included for analysis (n = 2957) (Webster, 2019). NPWT was associated with a reduced risk of surgical site infection (SSI) (23 studies [n=2547], relative risk [RR] 0.67; 95% CI, 0.53 to 0.85; I2=8.51%). However, subgroup analysis by surgery type only maintained a significant benefit for groin surgery (4 studies [n=206]; RR 0.48; 95% CI, 0.3 to 0.74; I2=0%) and did not show a significant difference for abdominal and colorectal surgery, Caesarean section, hip/knee arthroplasty, open fractures, vascular surgery, sternotomy surgery laparotomy, and mixed procedures. No significant difference was found for the rates of mortality and wound dehiscence between treatments. Certainty of evidence was deemed low per GRADE criteria, with only 3 trials allocating more than 100 participants. Very low-grade certainty evidence suggests a higher risk of developing skin blisters with NPWT (6 studies [n=597]; RR 6.64; 95% CI, 3.16 to 13.95). Studies were generally limited by imprecision and unclear or high-risk of bias in allocation concealment and blinding of outcome assessors. The analysis was also limited by inclusion of studies with mixed or unclear intervention types and no subgroup analysis for traditional and portable or single-use systems. Additionally, one study featured the use of a new generation V.A.C. device utilizing instillation. Nine studies identified the PICO system, 4 studies identified the Prevena system, 4 studies described but did not clearly identify portable or single-use devices, 3 studies identified the V.A.C. device, and 9 studies described but did not clearly identify an NPWT device.
A systematic review and meta-analysis by Li et al was conducted comparing the effectiveness and safety of NPWT with standard surgical dressing or conventional therapy for prevention of SSI (Li, 2019). A total of 45 RCTs assessing 6624 adult patients were included for analysis. Studies utilized a variety of NPWT devices, including V.A.C., PICO, and Prevena systems. Inclusion criteria did not impose restrictions on SSI grading systems or on surgery types. Surgeries for infected or chronic non-healing wounds including diabetic, venous, and arterial ulcers were excluded. Overall, NPWT was associated with a 40% reduction in SSI risk compared to control, with moderate heterogeneity (RR 0.58; 95% CI, 0.49 to 0.69; I2=19%; p<0.00001). This significant reduction in risk was particularly maintained in high-risk surgical patients (32 RCTs; RR 0.60; 95% CI, 0.50 to 0.73; I2=23%; p<0.00001). There was no significant effect of NPWT on wound dehiscence, hematoma occurrence, hospital admission, or length of hospital stay. The certainty of the evidence, based on GRADE criteria was graded as low to very low due to serious risk of bias stemming from lack of blinding and methodological flaws in SSI assessment and standardization. The authors suggest that further studies are warranted to elucidate the optimal protocol for NPWT utilization.
A 2013 Cochrane review of NPWT for treating foot wounds in patients with diabetes was updated in 2018 to include 11 RCTs (n=972) with sample sizes ranging from 15 to 341 participants (Dumville, 2013; Iheozor-Ejiofor, 2018). Two studies addressed post-amputation wounds and all other studies described treatment of diabetic foot ulcers. Only one study comparing NPWT and moist dressings for post-amputation wounds reported a follow-up time (n=162), and a statistically significant improvement in the proportion of wounds healed (RR 1.44, 95% CI, 1.03 to 2.01) was demonstrated after a follow-up duration of 16 weeks. The median time to healing was 21 days shorter for the NPWT group (hazard ratio 1.91, 95% CI, 1.21 to 2.99) compared with moist dressings. Data from 3 studies suggest that people with diabetic foot ulcers allocated to NPWT may be at reduced risk of amputation compared to moist dressings (RR 0.33, 95% CI, 0.15 to 0.70, I2=0%). Reviewers concluded that there was some evidence to suggest that NPWT was more effective than standard care, but the findings were uncertain due to the risk of bias in the unblinded studies. Reviewers recommended further study to reduce uncertainty around decision-making.
A systematic review by Wynn and Freeman evaluating NPWT for diabetic foot ulcers reported similar benefits in wound healing and the reduction of amputation incidence (Wynn, 2019). However, reviewers emphasized limitations in the present body of evidence, including methodological flaws such as the absence of validated tools for the measurement of wound depth and area, lack of statistical power calculations, and heterogeneity in pressure settings employed during therapy.
A 2018 Cochrane review evaluated the effects of NPWT for open traumatic wounds (eg, open fractures or soft tissue wounds) managed in any care setting (Iheozor-Ejiofor, 2018). Seven RCTs were identified for the review with sample sizes ranging from 40 to 586 participants. Four studies (n=596) compared NPWT at 125 mmHg with standard care for open fracture wounds. Pooled data revealed no significant difference between groups in the number of participants with healed wounds (RR 0.48, 95% CI 0.81 to 1.27; I2=56%). Pooled data from 2 studies (n=509) utilizing NPWT at 125 mmHg on other open traumatic wounds demonstrated no significant difference in risk of wound infection compared to standard care (RR 0.61, 95% CI, 0.31 to 1.18). One study (n=463) assessing NPWT at 75 mmHg against standard care in other open traumatic wounds did not demonstrate a significant difference for wound infection risk (RR 0.44, 95% CI, 0.17 to 1.10). One study comparing NPWT at 125 mmHg against 75 mmHg in other open traumatic wounds also failed to demonstrate a significant difference in wound infection risk (RR 1.04, 95% CI, 0.31 to 3.51). Evidence was deemed low to very low in certainty and quality due to imprecision and risk of bias.
In contrast, a systematic review and meta-analysis by Liu et al highlighted a significantly lower infection rate, shorter wound coverage time, shorter wound healing time, and shorter hospitalization duration for NPWT versus conventional wound dressings in the treatment of open fractures (all p<0.00001) (Liu, 2018). Three of 6 included RCTs overlapped with the Cochrane review and one significantly weighted RCT (n=460) failing to demonstrate a benefit in infection risk for NPWT was missing in the Liu et al analysis, the only RCT identified by Cochrane to conduct blinded outcome assessment of wound healing and infection (Liu, 2018; Costa, 2019). However, the risk of bias in the Liu et al review was similarly reported as high or unclear (Liu, 2018). The baseline characteristics of cohort studies included in the analysis suffered from high heterogeneity, with most studies failing to achieve comparable initial injury severity scores based on the Gustilo-Anderson open fracture classification system. Finally, due to the severity of open fracture injuries, the outpatient clinical utility of NPWT for this form of trauma is unclear with most studies focusing on inpatient applications.
Other randomized studies have reported no benefit for NPWT for surgical wounds, as reflected in the conclusions of various Cochrane reviews (Webster, 2014; Iheozor-Ejiofor, 2018). For example, the RCT by Masden et al examined the use of NPWT for surgical closures at high-risk for nonhealing in 81 patients with comorbidities that included diabetes and peripheral vascular disease (Masden, 2012). At a mean of 113 days follow-up, there were no significant differences in the proportions of patients with wound infection, time to develop infection or dehiscence between NPWT and dry dressing groups. Other examples include the trials by Chio and Biter that were previously discussed. (Chio, 2010; Biter, 2014)...
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 23. American Academy of Orthopaedic Surgeons (AAOS).(2022) Prevention of Surgical Site Infections After Major Extremity Trauma Evidence-Based Clinical Practice Guideline. www.aaos.org/SSItraumacpg. Published 03/21/22. Accessed November 15,2022. Argenta LC, Morykwas MJ.(1997) Vacuum-assisted closure: A new method for wound control and treatment: clinical experience. Ann Plast Surg 1997; 38:563-577. Armstrong DG, Lavery LA, Diabetic Foot Study Consortium.(2005) Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet, 2005; 366:1704-10. Armstrong DG, Marston WA, Reyzelman AM et al.(2011) Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized controlled trial. Wound Rep Regen 2011; 19(2):173-80. Baillot R, Cloutier D, Montalin L, et al.(2010) Impact of deep sternal wound infection management with vacuum-assisted closure therapy followed by sternal osteosynthesis: a 15-year review of 23,499 sternotomies. Eur J Cardiothorac Surg. 2010; 37(4):880-887. Banwell PE, Withey S, Holten I.(1998) The use of negative pressure to promote healing. Br J Plast Surg 1998; 51:79. Banwell PE.(1999) Topical negative pressure therapy in wound care. J Wound Care 1999; 8:79-84. Bapat V, El-Muttardi N, et al.(2008) Experience with vacuum-assisted closure of sternal wound infections following cardiac surgery and evaluation of chronic complications associated with its use. J Card Surg, 2008; 23:227-33. Baxadall T.(1997) Healing cavity wounds with negative pressure. Elder Care 1997; 9 :20-22. Bertges DJ, Smith L, Scully RE, et al.(2021) A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision. J Vasc Surg. Jul 2021; 74(1): 257-267.e1. PMID 33548422 Biter LU, Beck GM, Mannaerts GH, et al.(2014) The use of negative-pressure wound therapy in pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound therapy versus standard open wound care after surgical excision. Dis Colon Rectum. Dec 2014;57(12):1406-1411. PMID 25380007 Blackburn JH, Boemi L, Hall WW, et al.(1998) Negative pressure dressings as a bolster for skin grafts. Ann Plast Surg 1998; 40 :453-457. Bloemen MC, van der Wal MB, Verhaegen PD et al.(2012) Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial. Wound Repair Regen 2012; 20(6):797-805. Bloemen MC, van der Wal MB, Verhaegen PD, et al.(2012) Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial. Wound Repair Regen. Nov-Dec 2012;20(6):797-805. PMID 23110478 Bolton L et al.(2014) The Association for the Advancement of Wound Care (AAWC) Venous and Pressure Ulcer Guidelines. Ostomy Wound Manage. 2014;60(11):24–66. Braakenburg A, Obdeijn MC, Feitz R et al.(2006) The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plast Reconstr Surg 2006; 118(2):390-7. Canadian Coordinating Office for Health Technology Assessment.(2003) Vacuum assisted wound closure therapy. Issue 44, March 2003; www.ccohta.ca accessed 9-23-03. Chen L, Zhang S, Da J, et al.(2021) A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. Oct 2021; 10(10): 10830-10839. PMID 34763444 Chio EG, Agrawal A.(2010) A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing. Otolaryngol Head Neck Surg 2010; 142(2):174-8. Costa ML, Achten J, Bruce J, et al.(2018) Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial. JAMA. 2018 Jun 12;319(22):2280-2288. PMID: 29896626 Costa ML, Achten J, Parsons NR.(2022) Five-year outcomes for patients sustaining severe fractures of the lower limb: mid-term results from the Wound management for Open Lower Limb Fracture (WOLLF) trial. Bone Joint J. May 2022; 104-B(5):633-639. PMID 35491582 Cowan KN, Teague L, et al.(2005) Vacuum-assisted wound closure of deep sternal infections in high-risk patients after cardiac surgery. Ann Thorac Surg, 2005; 80:2205-12. Dalla Paola L, Carone A, Ricci S, et al(2010) Use of vacuum assisted closure therapy in the treatment of diabetic foot wounds. Journal of Diabetic Foot Complications. J. Diabetic Foot Complications. 2010;2:33-44. Damiani G, Pinnarelli l, Sommella L et al.(2011) Vacuum-assisted closure therapy for patients with infected sternal wounds: a meta-analysis of current evidence. J Plast Reconstr Aesthet Surg 2011 Jan 21 [Epub ahead of print]. Danne J, Gwini S, McKenzie D, et al.(2017) A retrospective study of pilonidal sinus healing by secondary intention using negative pressure wound therapy versus alginate or gauze dressings. Ostomy Wound Manage. Mar 2017;63(3):47-53. PMID 28355137 De Vries FE, Wallert ED, Solomkin JS, et al.(2016) A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery. Medicine (Baltimore). Sep 2016;95(36):e4673. PMID 27603360 DeFranzo AJ, Argenta LC, et al.(2001) The use of vacuum-assisted closure therapy for the treatment of lower-extremity wounds with exposed bone. Plast Reconstr Surg 2001; 108:1184-91. Doss M, Martens S, et al.(2002) Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis. Eur J Card Thorac Surg, 2002l 22:934-8. Dumville JC, Hinchliffe RJ, Cullum N et al.(2013) Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev 2013; 10:CD010318. Dumville JC, Land L, Evans D, et al.(2015) Negative pressure wound therapy for treating leg ulcers. Cochrane Database Syst Rev. 2015;7:CD011354. PMID 26171910 Dumville JC, Munson C, Christie J.(2014) Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev. 2014;12:CD006215. PMID 25500895 Dumville JC, Munson C.(2012) Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev 2012; 12:CD006215. Dumville JC, Owens GL, Crosbie EJ, et al.(2015) Negative pressure wound therapy for treating surgical wounds healing by secondary intention. Cochrane Database Syst Rev. 2015;6:CD011278. PMID 26042534 Dumville JC, Webster J, Evans D, et al.(2015) Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Syst Rev. 2015;5:CD011334. PMID 25992684 Eginton MT, Brown KR, et al.(2003) A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds. Ann Vasc Surg 2003; 17:645-9. Ehrl D, Heidekrueger PI, Broer PN, et al.(2017) Topical negative pressure wound therapy of burned hands: functional outcomes. J Burn Care Res. Mar 31 2017. PMID 28368916 Evans D, Land L.(2001) Topical negative pressure for treating chronic wounds. Cochrane Library; Issue 1, 2001. Evans D, Land L.(2003) Topical negative pressure for treating chronic wounds. Cochrane Library; Issue 2, 2003. FDA.(1997) Dermatologic and Ophthalmic Drugs. US Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee 46th Meeting transcripts 1997. FDA.(2000) Chronic cutaneous ulcer and burn wounds - developing products for treatment. Draft guidance for industry: US DHHS, FDA, Center for Biologics Eval and Research , Center for Devices and Radiologic Health, and Center for Drug Eval and Research. http:/www.fda.gov/cber/gdlns/ulcburn.pdf. Last accessed August 2000. Fleck TM, Fleck M, et al.(2002) The vacuum-assisted closure system for the treatment of deep sternal wound infections after cardiac surgery. Ann Thorac Surg, 2002; 74:1596-600. Fong KD, Hu D, Eichstadt SL et al.(2010) Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds 2010; 22(9):230-6. Ford CN, Reinhard ER, et al.(2002) Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the healthpoint system in the management of pressure ulcers. Ann Plast Surg 2002; 49:55-61. Gdalevitch P, Afilalo J, Lee C.(2010) Predictors of vacuum-assisted closure failure of sternotomy wounds. J Plast Reconstr Aesthet Surg 2010; 63(1):180-3. Glover JL, Weingarten MS, Buchbinder DS, et al.(1997) A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care 1997; 10:33-38. Gombert A, Babilon M, Barbati ME, et al.(2018) Closed Incision Negative Pressure Therapy Reduces Surgical Site Infections in Vascular Surgery: A Prospective Randomised Trial (AIMS Trial). Eur J Vasc Endovasc Surg. 2018 Sep;56(3):442-448. PMID: 29970335 Grauhan O, Navasardyan A, Hofmann M, et al.(2013) Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. May 2013;145(5):1387-1392. PMID 23111014 Greer SE, Longaker MT, Margiotta M, et al.(1999) The use of subatmospheric pressure dressing for the coverage of radial forearm free flap donor-site exposed tendon complications. Ann Plast Surg 1999; 43:551-554. Gregor S, Maegele M, Sauerland S et al.(2008) Negative pressure wound therapy: a vacuum of evidence? Arch Surg 2008; 143(2):189-96. Hersh RE, Jack JM, Dahman MI, et al.(2001) The vacuum-assisted closure device as a bridge to sternal wound closure. Ann Plast Surg 2001;46(3):250-4. Hersh RE, Kaza AK, et al.(2001) A technique for the treatment of sternal infections using the vacuum assisted closure devices. Heart Surg For, 2001; 4(3):211-5. Ho CH, Powell HL, Collins JF et al.(2010) Poor nutrition is a relative contraindication to negative pressure wound therapy for pressure ulcers: preliminary observations in patients with spinal cord injury. Adv Skin Wound Care 2010; 23(11):508-16. Hussamy DJ, Wortman AC, McIntire DD, et al.(2019) Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4). PMID 31503147 Iheozor-Ejiofor Z, Newton K, Dumville JC, et al.(2018) Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7:CD012522. PMID: 29969521 Joseph E, Hamori CA, Bergman S, et al.(2000) A prospective randomized trial of vacuum assisted closure versus standard therapy of chronic nonhealing wounds. Wounds 2000; 12:60-67. Kalailieff D.(1998) Vacuum-assisted closure: Wound care technology for a new millennium. Perspectives 1998; 22:28-29. Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R.(2013) Negative pressure wound therapy for management of the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013 Dec 18;2(12):276-84. PMID: 24352756 Karlakki SL, Hamad AK, Whittall C, et al.(2016) Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. Aug 2016;5(8):328-337. PMID 27496913 Kirsner R, Dove C, Reyzelman A, et al.(2019) A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. Sep 2019; 27(5): 519-529. PMID 31087729 Kirsner RS, Zimnitsky D, Robinson M.(2021) A prospective, randomized, controlled clinical study on the effectiveness of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities. Wound Repair Regen. Nov 2021; 29(6): 908-911. PMID 34525239 Krasner D, Margolis DJ, Ordona RU, et al.(1996) Prevention and management of pressure ulcers. Treatment of Chronic Wounds No. 6. Curative Health Services; Inc; East Setauket; NY 1996. Landsman A.(2010) Analysis of the SNaP Wound Care System, a negative pressure wound device for treatment of diabetic lower extremity wounds. J Diabetes Sci Technol 2010; 4(4):831-2. Lerman B, Oldenbrook L, Eichstadt SL et al.(2010) Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg 2010; 126(4):1253-61. Lerman B, Oldenbrook L, Ryn J et al.(2010) The SNaP Wound Care System: a case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds. J Diabetes Sci Technol 2010; 4(4):825-30. Li HZ, Xu XH, Wang DW, et al.(2019) Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis of randomized controlled trials. Clin Microbiol Infect. 2019 Nov;25(11):1328-1338. PMID: 31220604 Lipsky BA, Berendt AR, Cornia PB, et al.(2012) Infectious Diseases Society of America (IDSA), Clinical practice guideline for the diagnosis and treatment of diabetic foot infections. . Clinical Infectious Diseases 2012;54(12):132–173. http://cid.oxfordjournals.org/content/54/12/e132.full.pdf+html. Accessed November, 2014. Liu X, Zhang H, Cen S, et al.(2018) Negative pressure wound therapy versus conventional wound dressings in treatment of open fractures: A systematic review and meta-analysis. Int J Surg. 2018 May;53:72-79. PMID: 29555530 Marston WA, Armstrong DG, Reyzelman AM, et al.(2015) A Multicenter Randomized Controlled Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically Versus Electrically Powered Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). Feb 1 2015;4(2):75-82. PMID 25713749 Masden D, Goldstein J, Endara M, et al.(2012) Negative pressure wound therapy for at-risk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg. Jun 2012;255(6):1043-1047. PMID 22549748 Meara JG, Guo L, Smith JD, et al.(1999) Vacuum-assisted closure in the treatment of declotting injuries. Ann Plast Surg 1999; 42:589-594. Mendez-Eastman S.(1998) Negative pressure wound therapy. Plast Surg Nurs 1998; 18:27-29;33-37. Mendez-Eastman S.(1998) When wounds won't heal. RN 1998; 61:20-23. Mody GN, Nirmal IA, Duraisamy S et al.(2008) A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India. Ostomy Wound Manage 2008; 54(12):36-46. Monsen C, Acosta S, Mani K, et al.(2015) A randomised study of NPWT closure versus alginate dressings in peri-vascular groin infections: quality of life, pain and cost. J Wound Care. Jun 2015;24(6):252, 254-256, 258-250. PMID 26075373 Mooney JF, Argenta LC, Marks MW, et al.(2000) Treatment of soft tissue defects in pediatric patients using the VAC System. Clin Orth & Related Res 2000; 376:26-31. Morykwas MJ, Argenta LC, Shelton-Brown EI, et al.(1997) Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997; 38:553-562. Morykwas MJ, Argenta LC.(1997) Nonsurgical modalities to enhance healing and care of soft tissue wounds. J South Orthop Assoc 1997; 6:279-288. Moues CM, Vos MC, et al.(2004) Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial. Wound Repair Regen 2004; 12:11-7. Mullner T, Mrkonjic L, Kwasny O, et al.(1997) The use of negative pressure to promote the healing of tissue defects: A clinical trial using the vacuum sealing technique. Brit J Plas Surg 1997; 50:194-199. Murphy PB, Knowles S, Chadi SA, et al.(2019) Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann. Surg. 2019 Jul;270(1). PMID 30499799 National Institute for Health and Care Excellence (NICE).(2015) NICE Clinical Guideline NG19. Diabetic Foot Problems: Prevention and Management. 2015; https://www.nice.org.uk/guidance/ng19/evidence. Accessed December 22, 2015. Negative pressure wound therapy for wound Healing. Hayes Assessment. July 2003. Noble-Bell G, Forbes A.(2008) A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcers. Int Wound J 2008; 5(2):233-42. Norman G, Goh EL, Dumville JC, et al.(2020) Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. Jun 15 2020; 6: CD009261. PMID 32542647 Norman G, Shi C, Goh EL, et al.(2022) Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. Apr 26 2022; 4(4): CD009261. PMID 35471497 Nwomeh BC, Yager DR, Cohen IK.(1998) Physiology of the chronic wound. Clin Plast Surg 1998; 25:341-356. O'Leary DP, Peirce C, Anglim B, et al(2017) Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: The P.I.C.O. Trial. Ann Surg. Jun 2017;265(6):1082-1086. PMID 27926575 O’Connor J, Kells A, Henry S, Scalea T.(2005) Vacuum-assisted closure for the treatment of complex chest wounds. Ann Thorac Surg. 2005; 79(4):1196-1200. Pauser J, Nordmeyer M, Biber R, et al.(2014) Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. nt Wound J. Aug 14 2014. PMID 25125244 Peterson AT, Bakaysa SL, Driscoll JM, et al.(2021) Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. Sep 2021; 3(5): 100410. PMID 34058423 Philbeck TE Jr, Whittington KT, Millsay MH, et al.(1999) The clinical and cost effectiveness of externally applied negative pressure wound therapy in the treatment of wounds in home healthcare Medicare patients. Ostomy Wound Management 1999; 45:41-50. Ploumis A, Mehbod AA, Dressel TD et al.(2008) Therapy of spinal wound infections using vacuum-assisted wound closure: risk factors leading to resistance to treatment. J Spinal Disord Tech 2008; 21(5):320-3. Psoinos CM, Ignotz RA, Lalikos JF et al.(2009) Use of gauze-based negative pressure wound therapy in a pediatric burn patient. J Pediatr Surg 2009; 44(12):e23-6. Ramasastry SS.(1998) Chronic problem wounds. Clin Plast Surg 1998; 25:367-396. Rhee SM, Valle MF, Wilson LM, et al.(2014) Negative Pressure Wound Therapy Technologies For Chronic Wound Care in the Home Setting. Evidence Report/Technology Assessment. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-201-200007-I.) Rockville, MD: Agency for Healthcare Research and Quality. September 15, 2014. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id96ta.pdf. Accessed December 16, 2014. Rhee SM, Valle MF, Wilson LM, et al.(2015) Negative pressure wound therapy technologies for chronic wound care in the home setting: A systematic review. Wound Repair Regen. Jul 2015;23(4):506-517. PMID 25845268 Runkel N, Krug E, Berg L et al.(2011) Evidence-based recommendations for the use of negative pressure wound therapy in traumatic wounds and reconstructive surgery: Steps towards an international consensus. Injury 2011; 42(Suppl 1):S1-12. Samson DJ, Lefevre F, Aronson N.(2004) Wound-healing technologies: low-level laser and vacuum-assisted closure. www.ahrq.gov:AHRQ publication No. 05-E005-2; 2004. Schmelzle M, Alldinger I, Matthaei H et al.(2010) Long-term vacuum-assisted closure in open abdomen due to secondary peritonitis: a retrospective evaluation of a selected group of patients. Dig Surg 2010; 27(4):272-8. Scholl L, Chang E, et al.(2004) Sternal osteomyelitis: Use of vacuum-assisted closure device as an adjunct to definitive closure with sternotomy and muscle flap reconstruction. J Card Surg, 2004; 19:453-61. Schwartz JA, Goss SG, Facchin F, et al.(2015) Single-use negative pressure wound therapy for the treatment of chronic lower leg wounds. J Wound Care. Feb 2015;24 Suppl 2:S4-9. PMID 25647506 Seidel D, Diedrich S, Herrle F, et al.(2020) Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. Jun 01 2020; 155(6): 469-478. PMID 32293657 Seidel D, Diedrich S, Herrle F, et al.(2020) Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. Jun 01 2020;155(6): 469-478. PMID 32293657 Seidel D, Lefering R.(2022) NPWT Resource Use Compared With Conventional Wound Treatment in Subcutaneous Abdominal Wounds With Healing Impairment After Surgery: SAWHI Randomized Clinical Trial Results. Ann Surg. Feb 01 2022; 275(2): e290-e298. PMID 34117147 Seidel D, Storck M, Lawall H, et al.(2020) Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT. BMJ Open. Mar 24 2020; 10(3): e026345. PMID 32209619 Shilt JS, Yoder JS, Manuck TA et al.(2004) Role of vacuum-assisted closure in the treatment of pediatric lawnmower injuries. J Pediatr Orthop 2004; 24(5):482-7. Shirakawa M, Isseroff R.(2005) Topical negative pressure devices. Use for enhancement of healing chronic wounds. Arch Dermatol 2005; 141:1449-53. Simek M, Nemec P, et al.(2007) Vacuum-assisted closure in the treatment of sternal wound infections after cardiac surgery. Biomed Pap Med Fac, 2007; 151(2):295-9. Singh DP, Gabriel A, Parvizi J, et al.(2019) Meta-Analysis of Comparative Trials Evaluating a Single-Use Closed-Incision Negative-Pressure Therapy System. Plast Reconstr Surg. 2019 Jan;143:41S-46S. PMID: 30586103 Song DH, Wu LC, et al.(2003) Vacuum assisted closure for the treatment of sternal wounds: the bridge between debridement and definitive closure. Plast Reconstr Surg, 2003; 111:92-7. Stannard JP, Robinson JT, Anderson ER et al.(2006) Negative pressure wound therapy to treat hematomas and surgical incisions following high energy trauma. J Trauma 2006; 60(6):1301-6. Strugala V, Martin R.(2017) Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. PMID: 28885895 Svensson S, Monsen C, Kolbel T et al.(2008) Predictors for outcome after vacuum assisted closure therapy of peri-vascular surgical site infections in the groin. Eur J Vasc Endovasc Surg 2008; 36(1):84-9. Tang AT, Ohri SL, Haw MP.(2000) Novel application of vacuum assisted closure technique to the treatment of sternotomy wound infection. Eur J Cardiothorac Surg 2000; 17:482-4. Tocco MP, Costantino A, Ballardini M et al.(2009) Improved results of the vacuum assisted closure and Nitinol clips sternal closure after postoperative deep sternal wound infection. Eur J Cardiothorac Surg 2009 Feb 10 [Epub ahead of print]. Tuuli MG, Liu J, Tita ATN, et al.(2020) Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. Sep 22 2020; 324(12): 1180-1189. PMID 32960242 Ubbink DT, Westerbos SJ, Evans D et al.(2001) Topical negative pressure for treating chronic wounds. Cochrane Database Syst Rev 2008; (3):CD001898. Update of: Cochrane Database Syst Rev. 2001; (1):CD001898. Ugaki S, Kasahara S, Arai S et al.(2010) Combination of continuous irrigation and vacuum-assisted closure is effective for mediastinitis after cardiac surgery in small children. Interact Cardiovasc Thorac Surg 2010; 11(3):247-51. Van Rhee MA, de Klerk LW, Verhaar JA.(2007) Vacuum-assisted wound closure of deep infections after instrumented spinal fusion in six children with neuromuscular scoliosis. Spine J 2007; 7(5)596-600. Vikatmaa P, Juutilainen V, Kuukasjarvi P et al.(2008) Negative pressure wound therapy: a systematic review on effectiveness and safety. Eur J Vasc Endovasc Surg 2008; 36(4):438-48. Vuerstaek JD, Vainas T, Wuite J et al.(2006) State-of-the-art treatment of chronic leg ulcers: a randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg 2006; 44(5):1029-38. Wanner MB, Schwarzl F, et al.(2003) Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study. Scand J Plast Reconstr Hand Surg 2003; 37:28-33. Wasiak J, Cleland H.(2007) Topical negative pressure (TNP) for partial thickness burns. Cochrane Database Syst Rev 2007; (3):CD006215. Webster J, Liu Z, Norman G, et al.(2019) Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3:CD009261. PMID: 30912582 Webster J, Scuffham P, Stankiewicz M, et al.(2014) Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2014;10:CD009261. PMID 25287701 Williams DT; Maegele M, Gregor S, et al.(2006) Negative pressure therapy in diabetic foot wounds (letters & author reply). Lancet, 2006; 367:725-7. Willy C, Agarwal A, Andersen CA, et al.(2017) Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. Apr 2017;14(2):385-398. PMID 27170231 Wiseman J, Cullington JR, Schaeferle M, et al.(2001) Aesthetic aspects of neurofibromatosis reconstruction with the vacuum-assisted closure device. Aesthetic Plast Surg 2001; Sep-Oct; 25:326-31. www.ahrq.gov/clinic/ta/negpresswtd Wynn M, Freeman S.(2019) The efficacy of negative pressure wound therapy for diabetic foot ulcers: A systematised review. J Tissue Viability. 2019 Aug;28(3):152-160. PMID: 31056407 Xie X, McGregor M, Dendukuri N.(2010) The clinical effectiveness of negative pressure wound therapy: a systematic review. J Wound Care 2010; 19(11):490-5. Yang CC, Chang DS, Webb LX.(2006) Vacuum-assisted closure for fasciotomy wounds following compartment syndrome of the let. J Surg Orthop Adv 2006; 15(1):19-23. Yu L, Kronen RJ, Simon LE, et al.(2018) Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2):200-210.e1. PMID: 28951263 Zannis J, Angobaldo J, Marks M et al.(2009) Comparison of fasciotomy wound closures using traditional dressing changes and the vacuum-assisted closure device. Ann Plast Surg 2009; 62(4):407-9. |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|