CAM 10116

Negative Pressure Wound Therapy in the Outpatient Setting

Category:Durable Medical Equipment   Last Reviewed:August 2021
Department(s):Medical Affairs   Next Review:June 2022
Original Date:June 2013    

Description 
Negative pressure wound therapy (NPWT) involves the use of a negative pressure or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue and wound healing.

Background 
Chronic Wounds
Management
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.

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 nonpowered (mechanical) NPWT system has also been developed; the Smart Negative Pressure 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.

The focus of this evidence review is the use of NPWT in the outpatient setting. It is recognized that patients may begin using the device in the inpatient setting as they transition to the outpatient setting.

Regulatory Status
Negative pressure therapy or suction devices cleared by the U.S. Food and Drug Administration (FDA) for treating chronic wounds include, but are not limited to: Vacuum-Assisted Closure® Therapy (V.A.C., also known as negative pressure wound therapy; KCI); Versatile 1™ (V1) Wound Vacuum System (Blue Sky Medical), RENASYS™ EZ PLUS (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.

nonpowered NPWT device, the SNaP® Wound Care System (Spiracur, acquired by Acelity in 2015), is a class II device requiring notification to market but not having the FDA premarket approval. In 2009, it was cleared for marketing by the FDA through the 510(k) pathway (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, or 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, the FDA issued an alert concerning complications and deaths associated with NPWT systems. An updated alert was issued in February 2011.1,

FDA product code: OMP.

Related Policies
20116 Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Conditions
701113 Bio-Engineered Skin and Soft Tissue Substitutes

Policy
Initiation of a Powered and Non Powered Negative Pressure Wound Therapy (NPWT):

An initial therapeutic trial of not less than 2 weeks using a powered  or non powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors (e.g., diabetes, nutrition, relief of pressure), may be considered MEDICALLY NECESSARY 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
  • Wounds in patients with underlying clinical conditions that are known to negatively impact wound healing, which are nonhealing (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 NPWT.); OR 
  • Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure, AND there is no exposed bone, cartilage, tendon, or foreign material within the wound.

Continuation of Powered or Non Powered NPWT
Continuation of the powered  or non powered NPWT system, as part of a comprehensive wound care program, may be considered MEDICALLY NECESSARY following an initial 2-week therapeutic trial if the treatment trial has resulted in documented objective improvements in the wound, and if there is an ongoing objective improvement during subsequent treatment. 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 powered or Non Powered NPWT system is considered NOT MEDICALLY NECESSARY when any of the following occurs:

  • The therapeutic trial 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 the extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.

Therapeutic trials of powered  or non powered NPWT systems for the treatment of other acute or chronic wounds except as noted above are considered NOT MEDICALLY NECESSARY.

Use of single-use NPWT systems (powered or nonpowered) is investigational/unproven and therefore is considered NOT MEDICALLY NECESSARY for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds.

Policy Guidelines
Contraindications to the use of negative pressure wound therapy (NPWT) systems include the following conditions as noted by in a 2009 U.S. Food and Drug Administration (FDA) alert: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulae, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ.

In a 2011 update, FDA noted additional deaths and injury reports with NPWT since 2009. Although rare, these complications can occur wherever NPWT systems are used, including hospitals, long-term care facilities, and at home. Bleeding was the cause of the most serious adverse events, including deaths. Most reports of wound infection were related to the retention of dressing pieces in the wounds. FDA recommendations for health care providers include the following: select patients for NPWT carefully knowing that NPWT systems are contraindicated for certain wound types, and patient risk factors must be thoroughly considered before use; assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner; be aware of complications associated with dressing changes such as infection and bleeding; be vigilant for potentially life-threatening complications, such as bleeding; and be prepared to take prompt action if they occur. FDA reported that the safety and effectiveness of NPWT systems in newborns, infants, and children had not been established and, currently, there are no NPWT systems cleared for use in these populations.

Continuation of healing during use of the NPWT system should be monitored on a frequency of 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.

Powered or Non Powered NPWT systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing such as diabetes control, nutritional status, and relief of pressure.

The focus of these policy statements and guidelines is for the use of NPWT in the outpatient setting.

Coding
Please see the Codes table for details.

Supply Definitions:

HCPCS code E2402  A stationary or portable NPWT electrical pump that provides controlled sub atmospheric pressure that is designed for use with NPWT dressings, (K0539) to promote wound healing. 

HCPCS code A6550  A dressing set which is used in conjunction with a stationary or portable NPWT pump (K0538), and contains all necessary components, including but not limited to, a resilient open cell foam surface dressing, drainage tubing, and an occlusive dressing which creates a seal around the wound exudates. Coverage is provided up to a maximum of 15 dressing kits per month unless there is documentation that the wound size requires more than one (1) dressing kit for each dressing change. 

HCPCS code A7000  A canister set, which is used in conjunction with a stationary or portable NWPT (K0538) and contains all necessary components, including but not limited to a container to collect wound exudates. Canisters may be in various sizes to accommodate pump. Coverage is provided up to a maximum of 10 canister sets (A7000) per month unless there is documentation evidencing a large volume of drainage (greater than 90 ml/per day of exudates). For wounds with a high volume of exudates, a stationary pump with the largest capacity canister must be used. Excess utilization of canisters related to equipment failure will be denied as not medically necessary.

Amounts greater than 15 dressing kits (K0539) per wound per month or 10 canister sets (K0540) per month in the absence of documentation clearly explaining the medical necessity of the excess quantities will be denied as not medically necessary.

Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved or cleared devices may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

Rationale  
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The RCT is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

This review was informed by a 2000 TEC Assessment that evaluated negative pressure therapy of pressure ulcers, venous ulcers, and diabetic ulcers.2, Literature updates for this review have focused on comparative trials with the features described in the 2000 TEC Assessment (e.g., enrollment of patients with wounds refractory to standard treatment, randomization, optimal standard wound care treatment in the control arm, and clinically important endpoints). Also, literature has been sought on the potential benefits of negative pressure wound therapy (NPWT) for the healing of acute wounds.

NPWT devices are classified as either powered (i.e., requiring an electrical power source or batteries) or nonpowered (mechanical). Most evidence found in the literature is for electrically powered devices with large canisters (e.g., the Vacuum-Assisted Closure Therapy device [V.A.C. system]), and so 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 designed specifically for surgical incisions. Evidence on the newer portable devices is discussed following the review of evidence on the larger electrically powered devices.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the U.S. Food and Drug Administration (FDA) for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Systematic Reviews
The authors of a systematic review for the Agency for Healthcare Research and Quality and the Centers for Medicare & Medicaid Services (2014) reported that due to insufficient evidence, they were unable to draw conclusions about the efficacy or safety of NPWT in the home setting.4, There were 3 retrospective cohort studies on diabetic foot ulcers and arterial ulcers, an RCT and 2 retrospective cohort studies on pressure ulcers, and a retrospective cohort on venous ulcers. Six studies used the V.A.C., and the other used the Smart Negative Pressure (SNaP) Wound Care System device. Reviewers found that interpretation of available data was limited by variability in the types of comparator groups, methodologic limitations, and poor reporting of outcomes.5,

Another Agency for Healthcare Research and Quality assessment was performed to inform the HCPCS coding decisions for NPWT devices. This 2009 assessment found no studies showing a therapeutic distinction between different NPWT devices.6,

A 2020 Cochrane review update evaluated NPWT compared with standard dressings for surgical wound healing by primary closure.7, Forty-four RCTs were included for analysis (n=7447). NPWT was associated with a reduced risk of surgical site infection (SSI) (31 studies (n=6204); RR 0.66; 95% CI, 0.55 to 0.80; I2=23%). However, subgroup analysis by surgery type did not maintain a significant benefit for orthopedic, abdominal, or mixed/general surgeries. Treatment benefit for SSI was significant in clean and clean-contaminated procedures only. No significant difference was found for the rates of mortality and wound dehiscence. No significant benefit was seen for rates of reoperations or hospital readmissions. Certainty of evidence was deemed low to moderate per GRADE criteria. 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 or portable, single-use systems.

A systematic review and meta-analysis by Li et al. (2019) was conducted comparing the effectiveness and safety of NPWT with standard surgical dressing or conventional therapy for prevention of SSI.8, A total of 45 RCTs assessing 6,624 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.

Diabetic Lower-Extremity Ulcers and Amputation Wounds
Clinical Context and Therapy Purpose
The purpose of outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with diabetic lower-extremity ulcers or amputation wounds.

The question addressed in this evidence review is: Does NPWT improve outcomes when used for the outpatient treatment of diabetic foot ulcers and amputation wounds?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with diabetic lower-extremity ulcers or amputation wounds.

Interventions
The therapy being considered is outpatient NPWT, which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Though not completely standardized, follow-up for diabetic lower-extremity ulcers or amputation wounds symptoms would typically occur in the months to years after starting treatment.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
Systematic Reviews
A 2013 Cochrane review of NPWT for treating foot wounds in patients with diabetes9, was updated in 2018 to include 11 RCTs (n=972) with sample sizes ranging from 15 to 341 participants.10, Two studies addressed post-amputation wounds and all other studies described treatment of diabetic foot ulcers. Only 1 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 (2019) evaluating NPWT for diabetic foot ulcers reported similar benefits in wound healing and the reduction of amputation incidence.11, 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.

Randomized Controlled Trials
The largest study of NPWT for diabetic foot ulcers was a multicenter industry-sponsored RCT by Blume et al. (2008) that compared NPWT with advanced moist wound therapy.12, Included were 342 patients with Wagner grade 2 or grade 3 foot ulcers of at least 2 cm2; the chronicity of the ulcers was not described. Based on intention-to-treat analysis, a greater proportion of NPWT-treated foot ulcers achieved the primary endpoint of complete ulcer closure (43.2% vs. 28.9%, p=0.007) within the 112-day active treatment phase. For the 240 (72%) patients who completed the active treatment phase, 60.8% of NPWT-treated ulcers closed compared with 40.0% of ulcers treated with advanced moist wound therapy. NPWT patients also experienced significantly fewer secondary amputations (4.1% vs. 10.2%, p=0.035).

Nonrandomized Studies
Borys et al. (2018) conducted a prospective observational study to assess the short-term efficacy, safety, and long-term outcomes of NPWT in treating diabetic foot ulcers. Researchers assigned 75 patients to NPWT (n=53) or standard care (n=22) based on wound size. Analysis after 1-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.13,

Section Summary: Diabetic Lower-Extremity Ulcers and Amputation Wounds
The evidence on NPWT for diabetic lower-extremity ulcers and amputation wounds includes RCTs and systematic reviews of RCTs. Although there is some uncertainty due to the risk of bias in the unblinded studies, there were higher rates of wound healing and fewer amputations with NPWT, supporting its use for diabetic lower-extremity ulcers and amputation wounds.

Portable, Single-Use Therapy for Diabetic Lower-Extremity Ulcers and Amputation Wounds
Clinical Context and Therapy Purpose
The purpose of portable, single-use outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with diabetic lower-extremity ulcers or amputation wounds.

The question addressed in this evidence review is: Does portable, single-use NPWT improve outcomes when used for the outpatient treatment of diabetic foot ulcers and amputation wounds?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with nonhealing diabetic lower-extremity ulcers or amputation wounds.

Interventions
The therapy being considered is portable, single-use outpatient NPWT (powered or nonpowered), which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include standard wound care and standard, reusable NPWT devices.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Though not completely standardized, follow-up for diabetic lower-extremity ulcers or amputation wounds symptoms would typically occur in the months to years after starting treatment.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
PICO Dressing
PICO is a portable single-use NPWT system that comes with 2 sterile dressings and has a lifespan of 7 to 14 days.

Kirsner et al. (2019) published an RCT that allocated 164 patients with venous leg ulcers (VLU; n=104) or diabetic foot ulcers (DFU; n=60) to treatment with PICO single-use NPWT (s-NPWT; N=80) or traditional, reusable NPWT systems (t-NPWT; N=84).14, Prior to randomization, patients were excluded if a reduction in target ulcer area ≥30% was achieved with compression or offloading during a 2 week run-in period as a way to exclude 'quick healers.' Three patients in the t-NPWT arm were excluded from the intention-to-treat (ITT) analysis. For the per protocol (PP) analysis, 16 (20%) and 30 (37%) patients were excluded from the s-NPWT and t-NPWT arms, respectively. Randomization was stratified by wound type and wound size. The PICO dressing was set to provide -80 mmHg of negative pressure. Choice of traditional, NPWT device manufacturer and pressure setting was at the discretion of the treating physician, with an average pressure of -118.3 mmHg (median, -125 mmHg; SD, 23.4 mmHg) applied.

The study intended to test for noninferiority in the percentage change of target ulcer area with s-NPWT vs t-NPWT over the course of a 12 week treatment period, with a noninferiority margin of 12.5%. The analysis was performed with the PP population to account for dropouts and then repeated on the full analysis set (ITT). Secondary outcomes included wound closure rate, time to wound closure, and quality of life. Participants and investigators were not blinded, and it is unclear if the study utilized blinded assessors. Patients were seen weekly in outpatient wound centers. After adjustment for baseline wound area, pooled study site, wound type, and wound duration at baseline, the mean percentage difference in wound area over 12 weeks was 27% (96.9% vs 69.9%; P=0.003) in the PP analysis and 39.1% (90.24% vs 51%; P<0.001) in the ITT analysis. This treatment effect was also significant in the DFU subgroup (P=0.031). However, confidence intervals were not reported for the primary outcome.

Confirmed wound closure (ITT) was achieved in 54 (33.5%) patients (s-NPWT, 36 (45%); t-NPWT, 18 (22%)), with an adjusted odds ratio of 0.294 (95% CI, 0.135 to 0.638; P=0.002) for all wound types and 0.161 (95% CI, 0.035 to 0.744; P=0.020) for DFU. However, the subgroup analysis for DFU patients in the PP population was not significant.

The median estimate of the time to achieve confirmed closure was 77 days for s-NPWT (95% CI, 49 to undefined limit) and could not be calculated for t-NPWT due to the low number of patients achieving this endpoint. No significant differences were noted in health-related quality of life between baseline and exit visits. Fifty-seven treatment-related adverse events were reported, 16 related to s-NPWT in 12 patients and 41 related to t-NPWT in 29 patients. Wound-related adverse events included increase in target ulcer size, inability to tolerate NPWT, and periwound skin maceration, resulting in study discontinuation by 3 treated with s-NPWT and 9 treated with t-NPWT. While the PICO dressing met noninferiority, change in wound area is not a primary health outcome of interest due to its inherent heterogeneity. Additionally, the chosen treatment duration may have of insufficient duration to accurately assess effects on wound closure. Required use of fillers, a higher level of negative pressure, and utilization of devices from various t-NPWT manufacturers may have impacted findings. Only 20% of patients in the s-NPWT arm were treated with fillers, mainly in those with DFU.

SNaP Wound Care System
The portable, nonpowered (mechanical) gauze-based SNaP Wound Care System became available in 2009. The device is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic and pressure ulcers.

Armstrong et al. (2011) reported on results of a planned interim analysis of an RCT comparing the SNaP Wound Care System with the V.A.C. Therapy for the treatment of chronic lower-extremity wounds.15, Final results of this industry-sponsored multicenter noninferiority trial were reported in 2012.16, The trial enrolled 132 patients with lower-extremity venous or diabetic ulcers with a surface area between 1 cm2 and 100 cm2 and diameter less than 10 cm present for more than 30 days despite appropriate care. Approximately 30% of patients in this study had diabetic ulcers, and no subgroup analyses were conducted. Dressings were changed per the manufacturer’s direction: 2 times per week in the SNaP group and 3 times per week in the V.A.C. group. Patients were assessed for up to 16 weeks or until complete wound closure; 83 (63%) patients completed the study. Intention-to-treat analysis with the last observation carried forward showed noninferiority in the primary outcome of wound size reduction at 4, 8, 12, and 16 weeks. When adjusted for differences in wound size at baseline, SNaP-treated subjects showed noninferiority to V.A.C.-treated subjects at 4, 12, and 16 weeks. Kaplan-Meier analysis showed no significant difference in complete wound closure between the 2 groups. At the final follow-up, 65.6% of the V.A.C. group and 63.6% of the SNaP group had wound closure. Survey data indicated that dressing changes required less time with the SNaP device and use of the SNaP device interfered less with mobility and activity than the V.A.C. device.

A 2010 retrospective study with historical controls compared NPWT using the SNaP device (n=28) with wound care protocols using Apligraf, Regranex, and skin grafting (n=42) for the treatment of lower-extremity ulcers.17, Seven (25%) patients in the SNaP-treated group could not tolerate the treatment and were discontinued from the study because of complications; they were considered treatment failures. Between-group estimates of time-to-wound healing by Kaplan-Meier analysis favored the SNaP treatment group. This study is limited by the use of historical controls, multiple modalities to treat controls, and a large number of dropouts. Subgroup analyses for patients with diabetic (50%) and venous (50%) ulcers were not available. The authors noted that patients in the SNaP-treated group might have benefited from being in an experimental environment, particularly because wounds in this group were seen twice per week compared with variable follow-up in historical controls.

Section Summary: Portable, Single-Use Therapy for Diabetic Lower-Extremity Ulcers and Amputation Wounds
The evidence on portable, single-use NPWT for diabetic ulcers and amputation wounds includes an RCT of the PICO device and an RCT of the nonpowered SNaP System. A 2019 RCT compared the PICO device with standard NPWT in outpatients with diabetic and venous ulcers. In this study, the PICO device demonstrated noninferiority for wound area reduction. A statistically significant benefit in complete wound closure was noted for patients with diabetic ulcers, but was not duplicated in the per protocol population due to a high number of exclusions. Interpretation of this study is limited by variable device settings and short follow-up duration. One study of the SNaP System showed noninferiority to a V.A.C. device for wound size reduction. No significant difference in complete wound closure was reported. Interpretation of this study is limited by a high loss to follow-up. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed.

Chronic Pressure Ulcers
Clinical Context and Therapy Purpose
The purpose of outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with chronic pressure ulcers.

The question addressed in this evidence review is: Does NPWT improve outcomes when used for the outpatient treatment of chronic pressure ulcers?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with chronic pressure ulcers.

Interventions
The therapy being considered is outpatient NPWT, which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Though not completely standardized, follow-up for chronic pressure ulcers would typically occur in the months to years after starting treatment.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
Systematic Reviews
A 2015 Cochrane review included 4 RCTs of NPWT (total n=149 patients) for treating pressure ulcers in any care setting, although most of the patients were treated in a hospital setting.9, Three trials were considered to be at high-risk of bias, and all evidence was considered to be of very low-quality. Only 1 trial reported on complete wound healing, which occurred in only 1 of the 12 study participants. Reviewers concluded there is high uncertainty about the potential benefits and/or harms for this indication.

Randomized Controlled Trials
One representative trial, from 2003 (noted in the 2015 Cochrane review as “awaiting further information from the authors”), randomized 24 patients with pressure ulcers of the pelvic region to NPWT or standard wound care.18, All patients with pelvic pressure ulcers were eligible for enrollment and were not required to be refractory to standard treatment. There was no significant group difference for the main outcome measure, time to 50% reduction of wound volume (mean, 27 days in the NPWT group vs. 28 days in the control group). Findings were limited by the small number of patients in the study, the possibility that the control group might not have received optimal wound management, and lack of information on the time to complete wound healing.

Section Summary: Chronic Pressure Ulcers
The evidence on outpatient NPWT for chronic pressure ulcers includes RCTs and systematic reviews. However, all trials were of low-quality and at high-risk of bias. Also, most patients were treated in an inpatient setting.

Lower-Extremity Ulcers due to Venous Insufficiency
Clinical Context and Therapy Purpose
The purpose of outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with lower-extremity ulcers due to venous insufficiency.

The question addressed in this evidence review is: Does NPWT improve outcomes when used for the outpatient treatment of lower-extremity ulcers due to venous insufficiency?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with lower-extremity ulcers due to venous insufficiency.

Interventions
The therapy being considered is outpatient NPWT, which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include compression therapy and standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Though not completely standardized, follow-up for lower-extremity ulcers due to venous insufficiency symptoms would typically occur in the months to years after starting treatment.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
Randomized Controlled Trials
A 2015 Cochrane review of NPWT for venous insufficiency identified a single RCT with 60 patients.19,This trial, published by Vuerstaek et al. (2006), was performed in an inpatient setting in conjunction with skin grafts and compared the efficacy of NPWT using the V.A.C. system (n=30) with conventional moist wound care (n=30) in patients hospitalized with chronic venous and/or arterial leg ulcers of greater than 6 months in duration.20, 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 in the NPWT group and 45 days in the control group (p=0.001). Ninety percent of ulcers treated with NPWT healed within 43 days, compared with 48% in the control group. These results would suggest that NPWT significantly hastened wound healing, although the use of skin autografts makes it difficult to discern the contribution of NPWT to the primary outcome. The 2015 Cochrane review did not identify any RCT evidence on the effectiveness of NPWT as a primary treatment for leg ulcers, nor was there any evidence on the use of NPWT in the home setting.

Section Summary: Lower-Extremity Ulcers due to Venous Insufficiency
A single RCT has been identified on use of NPWT for the treatment of lower-extremity ulcers due to venous insufficiency in the hospital setting. No evidence was identified on treatment in the home setting.

Portable, Single-Use Therapy for Lower-Extremity Ulcers due to Venous Insufficiency
Clinical Context and Therapy Purpose
The purpose of portable, single-use outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with lower-extremity ulcers due to venous insufficiency.

The question addressed in this evidence review is: Does portable, single-use NPWT improve outcomes when used for the outpatient treatment of lower-extremity ulcers due to venous insufficiency?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with nonhealing lower-extremity ulcers due to venous insufficiency.

Interventions
The therapy being considered is portable, single-use outpatient NPWT (powered or nonpowered), which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include compression therapy, standard wound care, and standard, reusable NPWT devices.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Though not completely standardized, follow-up for lower-extremity ulcers due to venous insufficiency symptoms would typically occur in the months to years after starting treatment.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
PICO Dressing
Kirsner et al. (2019) published an RCT that allocated 164 patients with venous leg ulcers (VLU; n=104) or diabetic foot ulcers (DFU; n=60) to treatment with PICO single-use NPWT (s-NPWT; N=80) or traditional, reusable NPWT systems (t-NPWT; N=84).14, Additional study details and limitations are summarized previously in indication 2.

The primary outcome measure, mean percentage difference in wound area over 12 weeks, was 27% (96.9% vs 69.9%; P=0.003) in the per protocol (PP) analysis and 39.1% (90.24% vs 51%; P<0.001) in the intention-to-treat (ITT) analysis. This treatment effect was also significant in the VLU subgroup (P=0.007). However, confidence intervals were not reported. Confirmed wound closure (ITT) was achieved in 54 (33.5%) patients (s-NPWT, 36 (45%); t-NPWT, 18 (22%)), with an adjusted odds ratio of 0.294 (95% CI, 0.135 to 0.638; P=0.002) for all wound types and 0.398 (95% CI, 0.152 to 1.044; P=0.061) for VLU. The subgroup analysis for VLU patients in the PP population was also not significant.

SNaP Wound Care System
Armstrong et al. (2011) reported on results of a planned interim analysis of an RCT comparing the SNaP Wound Care System with the V.A.C. Therapy for the treatment of chronic lower-extremity wounds.15, Final results of this industry-sponsored multicenter noninferiority trial were reported in 2012.16, Approximately 70% of the study population had venous leg ulcers. Additional study details and limitations are summarized previously in indication 2.

A subgroup analysis (2015) of 40 patients with venous leg ulcers who completed the study showed a significant improvement in the percentage of those with complete wound closure treated with SNaP (57.9%) compared with the V.A.C. system (38.2%; p=0.008).21, However, this study had a high loss to follow-up and lacked a comparison with standard treatment protocols.

Section Summary: Portable, Single-Use Therapy for Lower-Extremity Venous Ulcers
The evidence on portable, single-use NPWT for lower-extremity venous ulcers includes an RCT of the PICO device and an RCT of the nonpowered SNaP System. A 2019 RCT compared the PICO device with standard NPWT in outpatients with diabetic and venous ulcers. In this study, the PICO device demonstrated noninferiority for wound area reduction. No significant benefit in complete wound closure was found in patients with venous ulcers. One study of the SNaP System showed noninferiority to a V.A.C. device for wound size reduction. A subgroup analysis of this study found a significant difference in complete wound closure for patients with venous ulcers. However, interpretation of this study is limited by a high loss to follow-up and a lack of a control group treated with standard dressings. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed.

Burn Wounds
Clinical Context and Therapy Purpose
The purpose of outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with burn wounds.

The question addressed in this evidence review is: Does NPWT improve outcomes when used for the outpatient treatment of burn wounds?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with burn wounds.

Interventions
The therapy being considered is outpatient NPWT, which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Follow-up at months to years if of interest to monitor relevant outcomes.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
Randomized Controlled Trials
A 2014 Cochrane review of NPWT for burn wounds identified an interim report (abstract) of an RCT on NPWT in patients with partial-thickness burns.22, The abstract did not provide enough evidence to draw any conclusions on the efficacy of NPWT on partial-thickness burn wounds.

Not included in the Cochrane review was a trial by Bloemen et al. (2012) on the effect of NPWT on graft take in full-thickness burn wounds.23, This multicenter, 4-armed RCT enrolled 86 patients and compared a split-skin graft with or without a dermal substitute (MatriDerm), with or without NPWT. Outcome measures included graft take at 4 to 7 days after surgery, the rate of wound epithelialization, and scar parameters at 3 and 12 months postoperatively. Graft take, and wound epithelialization did not differ significantly between groups. Most measures of scar quality also did not differ significantly between groups.

An expert panel convened to develop evidence-based recommendations for the use of NPWT reported that the evidence base in 2011 was strongest for the use of NPWT on skin grafts and weakest as a primary treatment for burns.24,

Case Series
A retrospective case series by Ehrl et al. (2017) examined outcomes for 51 patients treated for burned hands with topical NPWT 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.25,Before TNPW therapy, patients received escharotomy or superficial debridement if needed, or split-thickness skin grafts for third-degree burns and the NPWT gloves used allowed caregivers to assess patients’ fingertips for perfusion. Ergotherapy was initiated following evidence of epithelialization. Primary endpoints were a dorsal extension of the fingers and capability of complete active fist closure, with the majority of patients achieving 1 or both outcomes: the first endpoint was reached in 85.1% (n=40) of the cases; the second endpoint 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 NPWT as standard treatment at the institution from which these data were drawn.

Section Summary: Burn Wounds
The evidence on NPWT as a primary treatment of partial-thickness burns is limited. A retrospective case series reported functional outcomes in most patients treated for hand burns with NPWT. One RCT on NPWT for skin grafts showed no benefit for graft take, wound epithelialization, or scar quality.

Traumatic and Surgical Wounds
Clinical Context and Therapy Purpose
The purpose of outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with traumatic or surgical wounds.

The question addressed in this evidence review is: Does NPWT improve outcomes when used for the outpatient treatment of traumatic or surgical wounds?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with traumatic or surgical wounds.

Interventions
The therapy being considered is outpatient NPWT.

Comparators
Comparators of interest include standard wound care.

Outcomes
The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Follow-up within weeks to months if of interest for outpatient NPWT to monitor relevant outcomes.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Identified studies have described various wound types treated over periods ranging from several days to several months. Studies also differed by whether NPWT was used for nonhealing wounds or as a prophylactic treatment for surgical wounds in patients at high-risk for nonhealing.

Review of Evidence
Systematic Reviews
Selected systematic reviews and meta-analyses evaluating the use of NPWT in surgical and/or traumatic wounds are summarized in Table 1.

Table 1. Summary of SR-MAs of NPWT versus Standard Therapy in Surgical Wounds

Review RCT Other Studies Participants1 N (Range) Major Outcomes Study Quality Relevance
Cochrane (2014)26, 9 0 Individuals with wounds expected to heal by primary intention (eg, surgical closure, skin grafts) 785 SSI (NSD)
Wound dehiscence (NSD)
Reoperation (NSD)
Seroma/hematoma (NSD)
Skin graft failure (NSD)
Unclear or high risk of bias noted Unclear; inclusion of “home-made” devices and focus on inpatient therapy
De Vries et al. (2016)27, 6 15 Individuals treated with prophylactic NPWT in clean and contaminated surgery RCT: 277 (13-141)
Other: 1099 (23-237)
Surgical site infection (RCT: p=0.04; Other: p<0.00001; NSD for trauma/orthopedic surgery) Low quality of evidence due to lack of blinding in outcome assessment Unclear; focus on inpatient therapy
Cochrane (2018)10, 7 0 Individuals with open traumatic wounds (open fractures and other types) 1377 (40-586) Wound infection (NSD) Unclear or high risk of bias noted Limited; focus on inpatient therapy

NPWT: negative pressure wound therapy; NSD: no significant difference; RCT: randomized controlled trial; SR-MA: systematic review and meta-analysis; SSI: surgical site infection.
1  Key eligibility criteria,
2  Assessment according to Cochrane risk of bias criteria.

A 2014 Cochrane review evaluated the evidence on NPWT for skin grafts and surgical wounds expected to heal by primary intention.26, 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 (e.g., for chronic or infected wounds). Nine randomized trials (total n=785 patients) were included in the review. Three trials involved skin graft patients, 4 included orthopedic patients, and 2 included general surgery and trauma surgery patients. All trials had an unclear or high-risk of bias. There were no differences between standard dressing and NPWT for SSIs, 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 appeared to have used short-term application of NPWT in an inpatient setting.

A systematic review and meta-analysis by De Vries et al. (2016) included 6 RCTs and 15 observational studies of SSIs after prophylactic NPWT.27, 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 SSIs (odds ratio [OR], 0.56; 95% CI, 0.32 to 0.96; p=0.04), and reduced the SSI rate from 140 to 83 per 1,000 patients. However, the quality of evidence was rated as low due to high-risk of bias in the nonblinded assessments and imprecision in the estimates. Subgroup meta-analysis of 4 RCTs in orthopedic/trauma surgery did not demonstrate significant benefit in regards to reducing risk of SSI (OR 0.58; 95% CI, 0.32 to 1.07).

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.10, 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. (2018) 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).28, Three of 6 included RCTs overlapped with the Cochrane review and 1 significantly weighted RCT (n=460) (see Costa et al. (2018)29, in Table 2 below) failing to demonstrate a benefit in infection risk for NPWT was missing in the Liu et al. (2018) analysis, the only RCT identified by Cochrane to conduct blinded outcome assessment of wound healing and infection. However, the risk of bias in the Liu et al. (2018) review was similarly reported as high or unclear. 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.

Sahebally et al. (2018) performed a systematic review with meta-analysis to evaluate the effects of NPWT on SSIs in closed laparotomy incisions.30, Researchers searched 4 databases through December 31, 2017, and screened bibliographies of retrieved studies to find further studies; 9 unique studies (3 RCTs, 2 prospective studies, and 4 retrospective studies) representing 1,266 unique patients were included in the review. The analysis determined that NPWT was associated with a significantly lower rate of SSI compared with standard wound dressing (pooled OR: 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.

Randomized Controlled Trials
Selected RCTs of NPWT for surgical or traumatic wounds are summarized in Table 2.

Table 2. Summary of Key RCTs of NPWT versus Standard Therapy in Surgical Wounds

Study; Trial Surgery Received No. of Participants Notes on NPWT effectiveness P-value
Stannard (2012)31, Various, after fractures and other trauma 249 Fewer infections, less discharge than standard closure 0.049
Masden (2012)32, Various 81 NSD in infection or healing NR
Chio and Agrawal (2010)33, Radial forearm donor site 43 NSD in wound complications or graft failure NR
Javed (2018)34, Open pacreaticoduodenectomy 123 9.7% of NPWT group developed infections, compared with 31.1% of standard closure group 0.003
Tanaydin (2018)35, Bilateral breast reduction mammoplasty 32 Patients used as own control; NPWT associated with significantly lower risk of complication and improved pain and scarring compared with fixation strips <0.004
Costa (2018); WOLLF29, Severe open fracture of the lower limb 460 NSD in self-rated disability, number of deep SSI, or QOL scores Disability: 0.13
SSI: 0.64

QOL: NR
Seidel (2020); SAWHI36, Subcutaneous abdominal wound healing impairment 539 (randomized)
507 (modified ITT)
310 (PP)
Shorter time to wound closure and higher wound closure rate <0.001

ITT: intention-to-treat; NPWT: negative pressure wound therapy; NR: not reported; NSD: no significant difference; QOL: quality of life; PP: per protocol; RCT: randomized controlled trial; SSI: surgical site infection.

One of the largest studies on prophylactic NPWT for surgical wounds is a report from an investigator-initiated, industry-sponsored multicenter RCT of inpatient NPWT for closed surgical incisions by Stannard et al. (2012).31, (A preliminary report was published in 2006.)37, Participants included 249 blunt trauma patients with 263 high-risk fractures (tibial plateau, pilon, calcaneus) requiring surgical stabilization. Patients were randomized to NPWT applied to the closed surgical incision or to standard postoperative dressings. All trial participants were maintained as inpatients until wound drainage was minimal, at which time NPWT was discontinued (mean, 59 hours; range, 21-213 hours). Patients in the NPWT group were ready for discharge in 2.5 days compared with 3.0 days for the control group (the difference was not statistically significant). The NPWT group had significantly fewer infections (10% of fractures) than the control group (19% of fractures; p=0.049). Wound dehiscence after discharge was observed less frequently in the NPWT group (8.6%) than in the control group (16.5%). These results would support the efficacy of the short-term use of NPWT when used under highly controlled conditions of inpatient care, but not the effectiveness of NPWT in the outpatient setting. A small 2015 RCT (n=20) of NPWT in an outpatient setting reported that patients treated with NPWT required significantly fewer dressing changes, reported significantly less pain, and experienced QOL improvements compared with standard wound care.38,

Other randomized studies have reported no benefit for NPWT for surgical wounds, as reflected in the conclusions of various Cochrane reviews (described above).26,10, For example, the RCT by Masden et al. (2012) 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.32, 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. Chio and Agrawal (2010) published results of a randomized trial of 54 patients comparing NPWT with a static pressure dressing for the healing of the radial forearm free flap donor site.33, There were no statistically significant differences in wound complications or graft failure (percentage of area for graft failure, 7.2% for negative pressure vs 4.5% for standard dressing). Biter et al. (2014) found no significant advantage of 2 weeks of NPWT in 49 patients who underwent surgical excision for pilonidal sinus disease.39, Complete wound healing was achieved at a median of 84 days in the NPWT group and 93 days in controls.

Javed et al. (2018) conducted a single-site RCT to evaluate the efficacy of NPWT for SSI after an open pacreaticoduodenectomy. 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, an RR 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.34,

Tanaydin et al. (2018) conducted an RCT to compare NPWT to standard wound care after a bilateral breast reduction mammoplasty.35, In the study, 32 patients were given NPWT on 1 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.

The Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb (WOLLF) trial by Costa et al. (2018) randomized 460 patients with severe open fracture of the lower limb to NPWT (n=226) or standard wound management (n=234).29, The primary outcome was the Disability Rating Index score (range, 0 (no disability) to 100 (completely disabled)) at 12 months, with a minimal clinically important difference of 8 points. Secondary outcomes included deep infection and QOL measures based on the EuroQol 5-dimensions questionnaire. Eighty-eight percent of participants completed the trial. There were no statistically significant differences in disability scores (45.5 vs. 42.4; p=0.13), in the number of deep infections (16 (7.1%) vs. 19 (8.1%); p=0.64), or in quality of life measures in the NPWT and standard wound management groups, respectively.

The Subcutaneous Abdominal Wound Healing Impairment (SAWHI) multicenter clinical trial by Seidel et al. (2020) randomized adult patients with SAWHI to treatment with NPWT (V.A.C. Therapy) or conventional wound therapy (CWT).36, The modified ITT population included 256 and 251 patients assigned to NPWT and CWT, respectively. The primary outcome, mean time to wound closure within 42 days, was significantly shorter in the NPWT group (difference, 3.0 d; 95% CI, 1.6 to 4.4; P<0.001) and confirmed via independent, blinded assessors. Additionally, only 35.9% of patients in the NPWT group and 21.5% of patients in the CWT group achieved complete wound closure within 42 days (difference, 14.4%; 95% CI, 6.6% to 22.2%; P<0.001). While this met the prespecified non-inferiority margin of 12.5%, the study's statistical model had assumed a complete wound closure rate of 50% in the CWT arm which had not been met within the 42 day treatment period. The benefit of NPWT for these outcomes was sustained in the PP analysis, however, 39% and 31% of patients were excluded from the NPWT and CWT arms, respectively. Primary reasons for exclusion included unauthorized treatment crossovers, insufficient dressing changes, and treatment termination prior to 42 days. More wounds were sutured in the NPWT arm compared to the CWT arm, where more wounds healed by secondary intention. No significant differences were noted for quality of life or pain measures at any time point. The relative risk for adverse events (RR, 1.20; 95% CI, 0.97 to 1.47) and wound-related adverse events (RR, 1.51; 95% CI, 0.99 to 2.35) was higher in the NPWT arm. The most frequently documented wound-related adverse events in the NPWT arm included periwound macerations and local infections with signs of inflammation. Overall, it is unclear if a 3-day difference in time to wound closure represents a clinically meaningful benefit. Time to hospital discharge, readmission rates, and duration of outpatient care were not reported.

Section Summary: Traumatic and Surgical Wounds
The evidence on the use of NPWT for individuals who have traumatic or surgical wounds includes RCTs and systematic reviews. One RCT found no benefit of NPWT on graft take and wound epithelialization in patients with full-thickness burns. Another RCT found a significant decrease in time to wound closure in patients with wound healing impairment following abdominal surgery; however, it is unclear if this difference is clinically meaningful. In other studies, NPWT showed no benefit for the treatment of patients with surgical wounds or skin grafts healing by primary intention, and a systematic review of NPWT for traumatic and surgical wounds found no differences between standard dressing and NPWT for any wound outcome measure. However, a small RCT suggested that prophylactic NPWT might reduce the number of dressing changes and pain when used in an outpatient setting. A small retrospective study reported improved epithelialization in patients free of comorbidities treated with NPWT. Additional study in a larger, outpatient sample is needed to evaluate this outcome measure.

Portable, Single-Use Therapy for Traumatic and Surgical Wounds
Clinical Context and Therapy Purpose
The purpose of portable, single-use outpatient NPWT is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with traumatic and surgical wounds.

The question addressed in this evidence review is: Does portable, single-use NPWT improve outcomes when used for the outpatient treatment of traumatic or surgical wounds?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with traumatic or surgical wounds.

Interventions
The therapy being considered is portable, single-use outpatient NPWT (powered or nonpowered), which is administered in wound clinics and the home care setting. Outpatient NPWT does not include treatment at extended care facilities.

Comparators
Comparators of interest include treatment with standard, reusable NPWT devices or standard wound care.

Outcomes

The general outcomes of interest are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Follow-up at weeks to months is of interest for portable, single-use outpatient NPWT to monitor relevant outcomes.

The primary endpoints of interest for trials of wound healing are as follows, consistent with guidance from the FDA for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds:3,

  • Incidence of complete wound closure
  • Time to complete wound closure (reflecting accelerated wound closure)
  • Incidence of complete wound closure following surgical wound closure
  • Pain control

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.
  • Studies conducted exclusively in the inpatient setting were excluded.

Review of Evidence
PICO Dressing
PICO is a portable single-use NPWT system that comes with 2 sterile dressings and has a lifespan of 7 to 14 days. Karlakki et al. (2016) reported on an RCT with 220 patients that evaluated the use of the PICO device in a surgical center immediately after hip and knee arthroplasties.40, The device was left on for 7 days, including the time after the hospital stay. Strengths of the trial included powered intention-to-treat 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). However, 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 blister occurrence was reported to be reduced when the dressing was stretched less.

Prevena System
Pauser et al. (2016) reported on a small RCT (n=21) evaluating Prevena in patients who had hemiarthroplasty for femoral neck fractures.41, Use of the Prevena System significantly reduced seroma size, days of wound secretion, wound care time, and need for dressing changes.

Murphy et al. (2019) published findings from the Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE) trial, a single-center, superiority designed prospective randomized open blinded endpoint controlled trial evaluating the use of the Prevena System on closed incisions compared to standard gauze dressings in patients undergoing colorectal resection via laparotomy (n=300).42, The was no significant difference in the incidence of SSI at 30 days post-surgery between the Prevena and control groups (32% vs. 34%; p=0.68). No significant difference in length of hospital stay was reported.

Hussamy et al. (2019) reported on an open-label RCT evaluating the Prevena System for incisional NPWT following cesarean delivery in women with class III obesity (Body Mass Index ≥ 40; n=222) compared to standard dressings (n=219).43, The overall composite wound morbidity rate was not significantly different between the Prevena and control cohorts (17% vs. 19%; RR 0.9; 95% CI, 0.5 to 1.4).

Section Summary: Portable, Single-Use Therapy for Traumatic and Surgical Wounds
The evidence on portable single-use NPWT includes an RCT of the PICO device and RCTs of the Prevena Incision Management System. The PICO device was studied in an adequately powered but unblinded RCT of combined in- and outpatient use after total joint arthroplasty. The evidence base for the Prevena System is not sufficiently robust for conclusions on efficacy to be drawn. Well-designed comparative studies with larger numbers of patients treated in an outpatient setting are needed.

Summary of Evidence
For individuals who have diabetic lower-extremity ulcers or amputation wounds who receive outpatient NPWT, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life (QOL), and treatment-related morbidity. There was a higher rate of wound healing and fewer amputations with NPWT, although the studies were at risk of bias due to lack of blinding. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diabetic lower-extremity ulcers or amputation wounds who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A 2019 RCT compared the PICO device with standard NPWT. In this study, the PICO device demonstrated noninferiority for wound area reduction. A statistically significant benefit in complete wound closure was noted for patients with DFUs, but was not duplicated in the per protocol population due to a high number of exclusions. One study of the Smart Negative Pressure nonpowered Wound Care System (SNaP) showed noninferiority to a V.A.C. device for wound size reduction. No significant difference in complete wound closure was reported. Interpretation of this study is limited by a high loss to follow-up. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed. 

For individuals who have chronic pressure ulcers who receive outpatient NPWT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. All trials are of low-quality and at high-risk of bias. Also, most study populations were treated in inpatient settings. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive outpatient NPWT, the evidence includes an RCT and a systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A single RCT in patients with nonhealing leg ulcers who were treated with skin grafts found a faster rate of healing with NPWT when used in the inpatient setting. No studies were identified on the effectiveness of NPWT as a primary treatment for leg ulcers or for the use of NPWT in the outpatient setting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A 2019 RCT compared the PICO device with standard NPWT. In this study, the PICO device demonstrated noninferiority for wound area reduction. No significant benefit in complete wound closure was found in patients with venous ulcers. One study of the SNaP System showed noninferiority to a V.A.C. device for wound size reduction. A subgroup analysis of this study found a significant difference in complete wound closure for patients with venous ulcers. However, interpretation of this study is limited by a high loss to follow-up and a lack of a control group treated with standard dressings. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have burn wounds who receive outpatient NPWT, the evidence includes RCTs, systematic reviews, and case series. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. An interim report of an RCT evaluating NPWT in partial-thickness burns, summarized in a Cochrane review, did not permit conclusions on the efficacy of NPWT for this indication. A separate RCT comparing NPWT with split-skin grafts in patients with full-thickness burns did not show differences in graft take and wound epithelialization. A retrospective case series reported functional outcomes for most patients who were treated with NPWT at a single-center. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have traumatic or surgical wounds who receive outpatient NPWT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. There are limited data on NPWT as a primary treatment of partial-thickness burns. One RCT found no benefit of NPWT on graft take and wound epithelialization in patients with full-thickness burns. Another RCT found a significant decrease in time to wound closure in patients with wound healing impairment following abdominal surgery; however, it is unclear if this difference is clinically meaningful. In other studies, NPWT showed no benefit in the treatment of patients with surgical wounds or skin grafts healing by primary intention, and a systematic review of NPWT for traumatic and surgical wounds found no differences between standard dressing and NPWT for any wound outcome measure. However, a small RCT has suggested that prophylactic NPWT may reduce the number of dressing changes and pain when used in an outpatient setting. A small retrospective study reported improved epithelialization with NPWT in patients free of comorbidities. Additional study in larger, outpatient samples is needed to evaluate this outcome measure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have traumatic or surgical wounds who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. The PICO device was studied in an adequately powered but unblinded RCT of combined in- and outpatient use after total joint arthroplasty. The evidence base for the Prevena System is not sufficiently robust for conclusions on efficacy to be drawn. Well-designed comparative studies with larger numbers of patients treated in an outpatient setting are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2010 Input
In response to requests, input was received from 2 physician specialty societies and 3 academic medical centers while this policy was under review in 2010. The input was near uniform in support of a therapeutic trial of negative pressure wound therapy (NPWT) for chronic pressure ulcers that have failed to heal; for traumatic or surgical wounds that have failed to close when there is exposed bone, cartilage, tendon, or foreign material within the wound; and for nonhealing wounds in patients with underlying clinical conditions known to negatively impact wound healing. Most input affirmed that therapeutic trials of NPWT for other acute or chronic wounds would not be medically necessary.

Practice Guidelines and Position Statements
International Expert Panel on Negative Pressure Wound Therapy
In 2011, an international expert panel on NPWT provided evidence-based recommendations for the use of NPWT in chronic wounds.44, The panel made the following recommendations for the use of NPWT (see Table 3).

Table 3. Recommendations on Use of NPWT in Chronic Wounds

Condition Recommendation Gradea
Pressure ulcers, grade 3-4 “NPWT may be used until surgical closure is possible/desirable.” C
  “NPWT should be considered to achieve closure by secondary intention…. to reduce wound dimensions…. (and) to improve the quality of the wound bed.” B
Diabetic foot ulcers “NPWT must be considered as an advanced wound care therapy…. (and) must be considered to achieve healing by secondary intention.” A
  “NPWT should be considered in an attempt to prevent amputation or reamputation.” B
Ischemic lower-limb wounds “… NPWT … may be considered in specialist hands and never as an alternative for revascularisation.” C
  “… NPWT is NOT indicated in acute limb ischemia.” D
Venous leg ulcers “If first-line therapy (compression) is not efficacious, NPWT should be considered to prepare the wound for surgical closure….” B

NPWT: negative pressure wound therapy.
a  Grade A: based on high-quality meta-analyses, systematic reviews of RCTs, or RCTs with very low risk of bias; grade B: based on high-quality systematic reviews of case-control or cohort studies; Grade C: based on well-conducted case-control or cohort studies; Grade D: based on case series or expert opinion.

International Multidisciplinary Consensus Recommendations
Willy et al. (2017) presented evidence-based consensus guidelines on the use of closed incision negative pressure therapy (ciNPT) following surgery.45, 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 (i.e., 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.

Infectious Diseases Society of America and Surgical Infection Society
In 2011, guidelines for the prevention of infections associated with combat-related injuries were endorsed by the Infectious Diseases Society of America and the Surgical Infection Society.46, The guidelines provided an IB recommendation (strong recommendation, moderate-quality evidence) that NPWT should be used to manage open wounds (excluding central nervous system injuries).

The 2012 guidelines from the Society for the diagnosis and treatment of diabetic foot infections stated that no adjunctive therapy has been proved to improve the resolution of infection, but for select diabetic foot wounds that are slow to heal, clinicians might consider using NPWT (weak recommendation, low-quality evidence).47,

American College of Physicians
In 2015, the American College of Physicians published guidelines on the treatment of pressure ulcers.48, The guidelines stated there was low-quality evidence that the overall treatment effect of NPWT did not differ from the standard of care.

Association for the Advancement of Wound Care
In 2010, the Association for the Advancement of Wound Care (AAWC) published guidelines on the care of pressure ulcers. NPWT was included as a potential second-line intervention if first-line treatments did not result in wound healing (level B evidence). The guidelines indicated that patients must be selected carefully for this procedure. The guidelines were updated in 2014 with additional validation.49,

In 2010, the AAWC published guidelines on the care of venous ulcers.50, The guidelines listed NPWT as a potential adjunctive therapy if conservative therapy does not work in 30 days. The guidelines noted there is limited evidence for NPWT (level B) compared with other adjunctive therapies.

National Institute for Health and Care Excellence
In 2013, the National Institute for Health and Care Excellence (NICE) issued guidance on NPWT for surgical wounds, concluding that “current evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is adequate to support the use of this procedure.”51,

A 2015 NICE guidance on diabetic foot problems, updated in October 2019, has recommended consideration of NPWT after surgical debridement for diabetic foot ulcers on the advice of the multidisciplinary foot care service.52, 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.

In 2014, the NICE issued guidance on the prevention and management of pressure ulcers.53, The guidance stated, “Do not routinely offer adults negative pressure wound therapy to treat a pressure ulcer, unless it is necessary to reduce the number of dressing changes (for example, in a wound with a large amount of exudate).” Also, the guidance did not recommend NPWT for neonates, infants, or children.

A 2019 NICE guidance recommends the use of the PICO7 negative pressure wound dressing for closed surgical incisions due to their association with fewer surgical site infections and seromas compared to standard wound dressings.54, The device is considered an option for those who are at high risk for surgical site infections, which may be driven by several factors (e.g., age, underlying illness, obesity, smoking, wound classification, and site and complexity of procedure). The device is recommended for those with low to moderate levels of wound exudate who will require infrequent dressing changes.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 4.

Table 4. Summary of Key Trials

NCT No. Trial Name Planned Enrollment Completion Date
Ongoing      
NCT02664168 A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing) NR Feb 2020
(unknown)
NCT02348034a A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI) 398 Jul 2020
(recruiting)
NCT02467998 The Registry of Negative Pressure Wound Therapy for Chronic Wounds and Ulcers (NPWTR) 50,000 Jan 2020
(unknown)
NCT03144726 Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection 290 Jul 2020
(unknown)
NCT03716687 Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds: A Randomized Prospective Clinical Trial 300 Sep 2020
(recruiting)
NCT02509260 Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery 298 May 2021
(recruiting)
NCT03414762 PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery 400 Jul 2021
(recruiting)
NCT03948412 Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant (IMPART) 500 Sep 2021
(recruiting)
NCT04584957 Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial (GO-VAC) 196 Sep 2021
(ongoing)
NCT03773575a Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications (PREVENA-AMP) 440 Dec 2021
(recruiting)
NCT02682316a A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management 577 Feb 2022
(ongoing)
NCT04110353 Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives (ProNounCE) 570 Jun 2022
(not yet recruiting)
NCT04042259 Delayed Primary Closure Using Negative Pressure Wound Therapy 350 Dec 2022
(recruiting)
NCT01821664 Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy 1800 Mar 2023
(recruiting)
NCT01913132 PICO Versus Standard Dressing Above Groin Incisions After Vascular Surgery - A Prospective Randomized Trial 644 Dec 2024
(recruiting)
NCT02813161 A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice (DFUR) 10,000 Feb 2025
(recruiting)
Unpublished      
NCT02309944 Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients 93 June 2020
(completed)
NCT02799667 Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center? 110 Terminated
NCT01191567 Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient’s Quality of Life 200 Terminated
NCT02470806a A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers 164 Nov 2017
(completed)
NCT02395159 Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena) 204 Oct 2017
(completed)
NCT02739191 Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle 60 Aug 2017
(completed)
NCT02195310a The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences 342 Terminated
NCT02064270a A Prospective, Randomized, Controlled Clinical Study to Assess the Prevention of Postsurgical Incision Healing Complications in Patients Undergoing Primary or Revision Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA), Treated With Either Single-Use Negative Pressure Wound Therapy (NPWT) or Standard Postsurgical Dressings 526 Sep 2017
(completed)
NCT01890720a Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI ≥30 876 Dec 2016
(completed)

NCT: national clinical trial.
Denotes industry-sponsored or cosponsored trial.

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  49. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; https://s3.amazonaws.com/aawc-new/memberclicks/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed December 21, 2020.
  50. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG). Update of AAWC Venous Ulcer Guideline, 2005 and 2010. 2015; https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations-final%20v42%20changessaved18aug17.pdf. Accessed December 20, 2020.
  51. National Institute for Health and Care Excellence (NICE). Negative Pressure Wound Therapy for the Open Abdomen [IPG467]. 2013; https://www.nice.org.uk/guidance/ipg467. Accessed December 13, 2020.
  52. National Institute for Health and Care Excellence (NICE). Diabetic Foot Problems: Prevention and Management [NG19]. 2019; https://www.nice.org.uk/guidance/ng19/evidence. Accessed December 19, 2020.
  53. National Institute for Health and Care Excellence (NICE). Pressure ulcers: prevention and management [CG179]. 2014; https://www.nice.org.uk/guidance/cg179. Accessed December 14, 2020.
  54. National Institute for Health and Care Excellence (NICE). PICO negative pressure wound dressings for closed surgical incisions [MTG43]. 2019; https://www.nice.org.uk/guidance/mtg43. Accessed December 21, 2020.

Coding Section 

Codes Number Description
CPT 97605 Negative pressure wound therapy (e.g., 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
  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
HCPCS A6550 Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories
  A7000-A7001 Canister for use with suction pump, code range
  A9272 Wound suction, disposable, includes dressing and all accessories and components, any type, each
  E2402 Negative pressure wound therapy electrical pump, stationary or portable
  K0743 Suction pump, home model, portable, for use on wounds
  K0744-K0746 Code range for absorptive wound dressings to be used with home suction pump coded with K0743
ICD-10-CM L89.000-L89.899 Pressure ulcer code range, specified site, code range includes options for all body areas as well as designation of stages
  L89.90-L89.95 Pressure ulcer code range, unspecified site, code range includes options for stage of ulcer
  S01.00xA-S01.95xS Open wound of head and face, code range, 7th digit extender includes stage of healing
  S11.80xA-S11.95xS Open wound of neck, code range, 7th digit extender includes stage of healing
  S31.00xA-S31.839S Open wound of abdomen, lower back, pelvis and external genitals, code range, 7th digit extender includes stage of healing
  S41.001A-S41.159S Open wound of shoulder and upper arm, code range, 7th digit extender includes stage of healing
  S51.001A-S51.859S Open wound of elbow and forearm, code range, 7th digit extender includes stage of healing
  S61.001A-S61.559S Open wound of wrist, hand and fingers, code range, 7th digit extender includes stage of healing
  S71.001A-S71.159S Open wound of hip and thigh, code range, 7th digit extender includes stage of healing
  S81.001A-S81.859S Open wound of knee and lower leg, code range, 7th digit extender includes stage of healing
  S91.001A-S91.359S Open wound of ankle, foot and toes, code range, 7th digit extender includes stage of healing
ICD-10-PCS   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this therapy.
  6A0Z0ZZ Atmospheric control, single duration
  6A0Z1ZZ Atmospheric control, multiple durations
Type of Service Durable medical equipment  
Place of Service Home Inpatient Skilled nursing facility  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

08/16/2021 

Interim review, returning supply definitions and frequency to the policy. 

06/18/2021 

editing to correct typo. No other changes made. 

06/07/2021 

Annual review, policy updated to include: Separate indications for use of single-use devices in diabetic, venous, and surgical or traumatic wounds were created from the previous general section on single-use devices for any wound type. Policy statement regarding nonpowered NPWT devices for acute or chronic wounds was updated for clarity but maintained as investigational. Updated statement applies to single-use NPWT devices (powered or nonpowered) for acute or chronic wounds, including but not limited to diabetic, venous, surgical, or traumatic wounds. Also updating description, background, guidelines, rationale, references and coding. Also updating medical necessity criteria to mirror powered and nonpowered NPWT devices.

06/03/2020 

Annual review, no change to policy intent. Updating rationale and references. 

06/01/2019 

Annual review, no change to policy intent. Updating rationale and references. 

06/11/2018 

Annual review, no change to policy intent. Updating rationale and references. 

06/15/2017 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

05/12/2017 

Corrected review date. No other change. 

06/02/2016 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

06/29/2015 

Annual review with reorganization of information from guidelines into policy verbiage, removal of multiple issues previously considered as not medically necessary ( pneumonia, albumin less than 2, uncontrolled diabetes, thyroid disease or hypertension, use of systemic steroids and/or immunosuppressants, pregnancy or breast feeding. updated description of a complete wound care program. Change of statement from contraindicated to "use with caution" regarding active bleeding, anticoagulation therapy and difficult wound hemostasis. Also updated background, description, regulatory status, rationale, and references. Added coding.

06/10/2014

Annual review. Added related policies.  Updated rationale and references. No change to policy intent.


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