Medical Policy

Policy Num:       01.002.004
Policy Name:     Negative Pressure Wound Therapy in the Outpatient Setting
Policy ID:          [01.002.004]  [Ac / L / M+ / P+]  [1.01.16]

Last Review: October 24, 2024

Next Review: October 20, 2025

Related Policies:

05.001.006 - Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Conditions
02.001.018 - Electrostimulation and Electromagnetic Therapy for Treating Wounds
02.001.052 - Noncontact Ultrasound Treatment for Wounds
07.001.114 - Bioengineered Skin and Soft Tissue Substitutes

               Negative Pressure Wound Therapy in the Outpatient Setting

Summary

Description

Negative pressure wound therapy (NPWT) involves the use of 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.

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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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. By Clinical Input and as presented and approved in the Physician Advisory Board Triple-S will considered it medically necessary.

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.

Additional Information

Overall, the evidence from comparative clinical trials has demonstrated there is a subset of problematic wounds for which the use of NPWT may provide a significant clinical benefit. However, due to clinical variability and limited data, it is not possible to determine prospectively which wounds are most likely to respond favorably to NPWT. In addition, clinical input supports a therapeutic trial of NPWT for chronic pressure ulcers that have failed to heal, for traumatic or surgical wounds that have failed to close when there is exposed bone, cartilage, tendon, or foreign material within the wound, and for nonhealing wounds in patients with underlying clinical conditions known to negatively impact wound healing. Therefore, a therapeutic trial of NPWT of not less than 14 days may be considered medically necessary for chronic wounds that have failed to heal, despite intense conventional wound therapy for at least 90 days, or for wounds of at least 30 days that have a high probability of failure to heal due to compounding factors involving the wound and the patient. For continued use of NPWT beyond 14 days to meet criteria for medical necessity, there must be objective evidence of wound healing, such as the development of healthy granulation tissue and progressive wound contracture.

Objective

The objectives of this evidence review are to evaluate whether negative pressure wound therapy improves outcomes when used for the outpatient treatment of pressure ulcers, diabetic foot ulcers, venous ulcers, burn wounds, and traumatic or surgical wounds; and to assess the evidence on the use of portable, single-use negative pressure wound therapy devices.

Policy Statements

Initiation of Powered Negative Pressure Wound Therapy

An initial therapeutic trial of not less than 2 weeks using a powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors (eg, 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.

Continuation of Powered NPWT

Continuation of the 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 NPWT system is considered investigational 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 NPWT systems for the treatment of other acute or chronic wounds except as noted above are considered investigational.

Use of single-use NPWT systems (powered or nonpowered)is considered investigational 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 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.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

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 (ie, 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 (ie, healing by secondary intention) or preparation for wound closure with skin grafts or flaps (ie, 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.

A 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.

Rationale

This evidence review was developed in January 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 14, 2023.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to 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 a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use 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 randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials 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.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

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 (eg, 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.

Negative pressure wound therapy devices are classified as either powered (ie, requiring an electrical power source or batteries) or nonpowered (mechanical). Most evidence found in the literature is for electrically powered devices with large canisters (eg, 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.

Generally, in a heterogeneous population, the evidence is uncertain for home use of NPWT. 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,

Population Reference No. 1 

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 diabetes^9, 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.

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.

Population Reference No. 2

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.

Summary of Evidence

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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3

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.

Summary of Evidence

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. By Clinical Input and as presented and approved in the Physician Advisory Board Triple-S will considered it medically necessary.

Population Reference No. 4

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.

Summary of Evidence

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.

Population Reference No. 5

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.

Summary of Evidence

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.

Population Reference No. 6

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.

Summary of Evidence

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.

Population Reference No. 7

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

 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 (eg, 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 1000 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 1266 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

 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.

Summary of Evidence

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. By Clinical Input and as presented and approved in the Physician Advisory Board Triple-S will considered it medically necessary.

Population Reference No. 8

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 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.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

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

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS) 2022 guidelines for prevention of surgical site infections after major extremity trauma included recommendations for NPWT.^45, The recommendations from AAOS do not support the continued use of NPWT in patients undergoing fracture fixation due to similar outcomes to standard wound care but with an increased healthcare burden. In patients with high-risk surgical incisions, the AAOS recommends that limited evidence suggests NPWT may be an option; however, its use will be influenced by cost. Importantly, these guidelines do not specifically address use in the outpatient setting.

American College of Physicians

In 2015, the American College of Physicians published guidelines (now inactive) on the treatment of pressure ulcers.^46, The guidelines stated there was low-quality evidence that the overall treatment effect of NPWT did not differ from the standard of care. Of note, the American College of Physicians considers these guidelines inactive since they are more than 5 years old.

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. Negative pressure wound therapy 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.^47,

In 2010, the AAWC published guidelines on the care of venous ulcers.^47, 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.

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.^48, Among the studies found were 100 randomized controlled studies on ciNPT, most of which found an association between the use of ciNPT and improved outcomes. Based on the evidence, the consensus panel recommended that surgeons evaluate risk in patients before surgery to determine whether patient comorbidities (ie, obesity or diabetes) or the nature of the surgery presents an increased danger of infection. In such cases, the panel recommended the use of ciNPT.

Infectious Diseases Society of America and International Working Group on the Diabetic Foot

A 2023 guideline from the Society for the diagnosis and treatment of diabetic-related foot infections (DFIs) makes the following recommendation relevant to NPWT: "We suggest not using the following treatments to address DFIs: (a) adjunctive granulocyte colony-stimulating factor (G-CSF) treatment or (b) topical antiseptics, silver preparations, honey, bacteriophage therapy, or negative-pressure wound therapy (with or without instillation)."^49, This was graded as a conditional recommendation with low-quality evidence.

National Institute for Health and Care Excellence

In 2013, 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.”^50,

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.^51, 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, NICE issued guidance on the prevention and management of pressure ulcers.^52,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.^53, The device is considered an option for those who are at high risk for surgical site infections, which may be driven by several factors (eg, 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.

A 2021 NICE guidance on cesarean birth recommends considering the use of NPWT for women with a body mass index ≥35 kg/m² to reduce the risk of wound infections.^54, Routine use of NPWT following cesarean delivery is not recommended. These recommendations were unchanged in a 2023 update to this guidance.

A 2021 NICE guidance states that while the V.A.C. Veraflo Therapy system shows promise in the treatment of acute infected or chronic non-healing wounds, there is not enough high-quality evidence to support the case for routine adoption.^55, The guidance recommends research in the form of an RCT comparing the V.A.C. Veraflo Therapy system (NPWT with wound instillation) to NPWT alone.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

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: national clinical trial; NR: not reported.  a Denotes industry-sponsored or cosponsored trial.

References

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51. National Institute for Health and Care Excellence (NICE). Diabetic Foot Problems: Prevention and Management [NG19]. Published August 2015; Updated October 2019; https://www.nice.org.uk/guidance/ng19/evidence. Accessed November 14, 2023.
52. National Institute for Health and Care Excellence (NICE). Pressure ulcers: prevention and management [CG179]. 2014; https://www.nice.org.uk/guidance/cg179. Accessed November 10, 2023.
53. 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 November 16, 2023.
54. National Institute for Health and Care Excellence (NICE). Cesarean birth [NG192]. Published: March 2021. Updated: September 2023; https://www.nice.org.uk/guidance/ng192. Accessed November 15, 2023.
55. National Institute for Health and Care Excellence (NICE). The VAC Veraflo Therapy system for acute infected or chronic wounds that are failing to heal [MTG54]. 2021; https://www.nice.org.uk/guidance/mtg54. Accessed November 9, 2023.

Codes

Policy History