Medical Policy: 01.01.20
Original Effective Date: September 2012
Reviewed: April 2020
Revised: April 2019
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
This policy applies to the use of non-powered negative pressure wound therapy (NPWT) systems (mechanical or single use (disposable) battery operated devices) in the outpatient setting.
The management and treatment of chronic wounds, including decubitus ulcers, is challenging. Most chronic wounds will heal only if the underlying cause (i.e., venous stasis, pressure, infection) is addressed. Also, cleaning the wound to remove nonviable tissue, microorganisms, and foreign bodies is essential to create optimal conditions for either re-epithelialization (i.e., healing by secondary intention) or preparation for wound closure with skin grafts or flaps (i.e., healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.
Negative pressure wound therapy (NPWT) involves the use of a negative pressure 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. The devices may also be used as an adjunct to surgical therapy or as an alternative to surgery. Although the exact mechanisms 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.
Negative pressure wound therapy (NPWT) devices are classified as either powered (i.e. requiring an electrical power source) or non-powered (mechanical) or battery operated. Most evidence found in the literature is for electrically powered devices with large canisters (e.g. such as vacuum-assisted devices). A number of non-powered negative pressure wound therapy (single use) portable devices have entered the market for use in the outpatient setting. Some non-powered negative pressure wound therapy (single use) portable devices are designed specifically for surgical incisions.
Conventional NPWT using a powered negative pressure wound therapy system can be bulky and intrusive for patients who are ambulatory and active, disposable non-powered negative pressure wound therapy (NPWT) (mechanical) or single use (disposable) non-powered (battery operated) negative pressure wound therapy have been proposed for the treatment of small to medium sized, slow to heal wounds and also for the management of surgical incisions. The goal of these devices is to make it easier to use by both the clinicians and patients. Specifically, the device should be one that clinicians can take off the shelf like any other wound care dressing, it is quick and easy to apply, and the patients can wear under their clothes and will not impinge on their normal activities. The idea was to make it practical and cost effective, allowing more patients to benefit from NPWT in the outpatient/home setting.
The purpose of portable single-use outpatient negative pressure wound therapy (NPWT) devices is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with any wound type (acute or nonhealing).
The relevant population of interest is individuals with any wound type (acute or nonhealing).
The therapy being considered is portable single-use outpatient NPWT.
Comparators of interest include standard negative pressure wound therapy (NPWT).
The general outcomes of interest are symptoms, change in disease status, quality of life (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 Smart Negative Pressure (SNaP) Wound Care System (Spiracur, Sunnyvale, CA) is a disposable, ultraportable NPWT device that does not require an electrically-or-battery powered pump. The SNaP System is a mechanically-powered NPWT system comprising spring technology that reduces air density within an enclosure in a controlled manner. The specialized springs equilibrate even in the presence of exudate so that a constant controlled amount of negative pressure is delivered to the wound bed. Because there is no electrical pump, operation of the SNaP System is completely silent, and it is small enough to be worn on a patient's leg, arm or belt and hidden underneath clothing.
The (SNaP) Wound Care System consists of three basic elements; the cartridge with activation/reset key, the hydrocolloid dressing layer, and the strap with attachment clip.
The hydrocolloid dressing is used over a wound filling material consisting of specialized SNaP Blue foam dressing or antimicrobial gauze dressing.
The SNaP System is indicated for the removal of small amounts of exudate from the following types of wounds:
The SNaP System should not be used over:
It is recommended that the dressing be changed at least two times per week by the patient’s healthcare provider. The frequency of the dressing changes will depend on a number of factors (e.g. the level of exudate, bacterial load and rate of granulation tissue).
In 2011, Armstrong and colleagues reported results of a planned interim analysis of a randomized controlled trial (RCT) comparing the SNaP device and the V.A.C.®(Negative pressure therapy Assisted Closure®) Therapy™ (Kinetic Concepts, Inc., San Antonia, TX) for the treatment of chronic lower extremity wounds. The study randomized 132 patients with lower extremity venous or diabetic ulcers of varying size and present more than 30 days despite appropriate care. Dressings were changed per manufacturer direction, 2 times per week in the SNaP group and 3 times per week in the V.A.C. group. Patients were assessed for up to 16 weeks or until complete wound closure; 83 patients (63%) completed the study. Intention-to-treat analysis with the last observation carried forward showed non-inferiority 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 non-inferiority to the VAC-treated subjects at 4, 12, and 16 weeks. Kaplan-Meier analysis showed no significant difference in complete wound closure between the two groups. At the final follow up, 65.6% of the VAC group and 63.6% of the SNaP group had wound closure. Survey data indicated that dressing changes required less time, and the use of the SNaP device interfered less with mobility and activity than the V.A.C. device. This study is limited by the high loss to follow-up and the lack of comparison with standard treatment protocols.
A 2010 retrospective study with historical controls compared negative pressure wound therapy using the SNaP device (n=28) with wound care protocols that included the use of Apligraf (Novartis), Regranex (Healthpoint Ltd.), and skin grafting (n=42) for treatment of lower extremity ulcers. Seven patients (25%) in the SNaP-treated group could not tolerate the treatment and were discontinued from the study because of complications (allergic skin reaction, wound infection, bleeding after debridement preventing reapplication, worsening lower extremity edema, and the development of maceration severe enough to require discontinuation) and were considered treatment failures. Between-group estimates of time-to-wound healing by Kaplan-Meier analysis favored the SNaP treatment group. The study is limited by the use of historical controls, the multiple modalities used in treatment of controls, and the large number of dropouts. The authors noted that patients in the SNaP treated group may have benefitted from being in an experimental environment, particularly because wounds in this group were seen twice per week compared to variable follow-up in the historical controls.
Other publications have described use of the SNaP device in case series with small numbers of patients, fewer than 15 patients.
PICO™ Single Use Negative Pressure Wound Therapy (Smith and Nephew, St. Petersburg, FL) is a pocket sized disposable single use negative pressure wound therapy system. The PICO™ device consists of a small, portable pump with a lifespan of up to 7 days. The PICO™ pump generates an effective negative pressure of 80mmHg yet is small enough to fit discretely into a pocket.
The PICO™ pump is connected to a specially designed dressing which: 1) maintains the negative pressure across the wound bed and 2) removes the exudate from the wound bed through absorbency and evaporation. In each carton there is one pump plus two AA lithium batteries and two separately packed dressings complete with fixation strips. This enables a dressing change to be carried out within the lifespan of the pump if this is clinically necessary.
PICO™ Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low levels of exudates and infectious materials. Examples of appropriate wound types include:
In 2017, O’Leary et. al. conducted a randomized, controlled open-label trial to investigate the effect of prophylactic negative pressure dressings on postoperative surgical site infection (SSI) in closed laparotomy wounds. Laparotomy wounds are associated with high rates of SSI. The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rate is unknown. Fifty patients undergoing open abdominal surgery were included, with 25 patients randomized to the negative pressure dressing group and 25 to the standard dressing group. The primary endpoint was SSI incidence at 30 days postoperatively. Secondary endpoints included SSI incidence at 4 days, length of stay, cosmetic outcome, and patient satisfaction. Statistical analysis was performed on a per-protocol basis using SPSS version 23.0. The incidence of SSI at 30 days postoperatively was significantly reduced in the treatment group compared with the control group [8.3% vs 32.0%, P = 0.043 (1-sided), P = 0.074 (2-sided)]. There was no difference in SSIs at 4 days postoperatively [4.1% vs 8.0%, P = 0.516 (1-sided), P = 1.0 (2-sided)]. Analysis of predictors of wound infection identified standard wound dressings as the only significant predictor of SSI development. Length of stay was significantly reduced in the negative pressure dressing group [6.1 vs 14.7 days, P = 0.019 (2-sided)]. Cosmetic outcome and patient satisfaction did not show any difference between the 2 groups. The mean length of stay was shorter for patients who received negative pressure dressings (6.1 days) than for control patients; however, when all reasons for delayed discharge were accounted for, the difference was not statistically significant (p=0.89). While comparatively small, this trial would indicate that negative pressure dressings resulted in a beneficial outcome for patients recovering from abdominal surgery regarding the occurrence of SSIs.
Strugala et. al. (2017) published a meta-analysis on the impact of prophylactic use of a specific design of negative pressure would therapy (NPWT) device on surgical site complications. Articles were identified in which the specific single-use NPWT device (PICOâ‹„, Smith & Nephew) was compared with standard care for surgical site infection (SSI), dehiscence, or length of stay (LOS). Risk ratio (RR) ±95% confidence interval (CI) (SSI; dehiscence) or mean difference in LOS ±95% CI was calculated using RevMan v5.3. There were 1863 patients (2202 incisions) represented by 16 articles. Among 10 randomized studies, there was a significant reduction in SSI rate of 51% from 9.7% to 4.8% with NPWT intervention (RR 0.49 [95% CI 0.34-0.69] p < 0.0001). There were six observational studies assessing reduction in SSI rate of 67% from 22.5% to 7.4% with NPWT (RR 0. 32 [95% CI 0.18-0.55] p < 0.0001). Combining all 16 studies, there was a significant reduction in SSI of 58% from 12.5% to 5.2% with NPWT (RR 0.43 [95% CI 0.32-0.57] p < 0.0001). Similar effects were seen irrespective of the kind of surgery (orthopedic, abdominal, colorectal, or cesarean section), although the numbers needed to treat (NNT) were lower in operations with higher frequencies of complications. There was a significant reduction in dehiscence from 17.4% to 12.8% with NPWT (RR 0.71 [95% CI 0.54-0.92] p < 0.01). The mean reduction in hospital LOS by NPWT was also significant (-0.47 days [95% CI -0.71 to -0.23] p < 0.0001). It is unclear whether included studies captured outpatient utilization of the device.
In 2016, Karlakki et al reported an RCT with 220 patients that evaluated use of the PICO device in the surgical center immediately after hip and knee arthroplasties. The primary outcome was to measure the impact of single use iNPWTd (incisional negative pressure wound therapy dressing) on wound healing and effect on length of stay (LOS). The device was left on for 7 days, including time after the hospital stay. Strengths of the study included power and ITT analysis, but evaluators were not blinded. There were trends toward reductions in hospital length of stay (0.9 days; 95% CI, -0.2 to 2.5 days; p=0.07) and postoperative surgical wound complications (8.4% control vs 2.0% PICO, p=0.06). Most of the difference in length of stay was due to wound complications in 2 outliers in the control group (up to 61 days). The level of wound exudate was significantly reduced by the PICO device (p=0.007), with 4% of the study group and 16% of the control group having grade 4 (scale grade, 0-4) exudate. Blisters were observed in 11% of patients treated with the PICO system, although the occurrence of blisters was reported to be reduced when the dressing was stretched less. There were a number of limitations to this study: a) this was non-blinded study; b) the routine practice of changing wound dressings at second day post-surgery and working towards expected date of discharge (four days post-surgery at the time of study period) was difficult to control due to the number of nursing staff involved in patient care; c) the incidence of surgical wound complications was recorded rather than directly inspected as the information was obtained over the telephone at the two week telephone check; d) wound-related data were not collected following protocol failure, which meant an ITT analysis was not possible for LOS; and e) unable to standardize the wound closure methodology, as this would have meant changing surgeons’ practice.
In 2015, Schwartz et. al. reported an industry funded pilot study with 12 patients who had lower extremity chronic small wounds of various types (total 13 wounds) treated with single use negative pressure wound therapy (NPWT). The aim of this study was to assess the efficacy of single use NPWT on chronic lower extremity wounds that are usually deemed to small or superficial for traditional NPWT. A key inclusion criterion was complete failure to progress over the previous 4 weeks. During the 4 weeks of PICO application, wound size decreased and wound appearance improved. There was no control group in this pilot study and no wound closures during short follow-up period.
V.A.C.Via™ Therapy System (KCI, San Antonio, TX) is a portable single patient use negative pressure wound therapy device that offers 7 days of therapy. Provides dynamic pressure control and continuous negative pressure options of 75mmHg or 125mmHg.
The system is designed for moderate to lower-severity wounds and provides the same clinical efficacy as current V.A.C.® therapy products. The V.A.C.Via™ System creates an environment that promotes healing by: 1) maintaining a moist wound healing environment, 2) remove excess wound fluids and infectious material and 3) creating an environment that promotes perfusion and granulation tissue formation.
V.A.C.Via™ Therapy System is indicated for open wound types including: chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
In a retrospective study, Gabrielle et al. (2013) evaluated use of the disposable, single-patient-use NPWT system (SP-NPWT) V.A.C.Via™ Therapy over dermal regeneration template (DRT) and/or skin grafts. SP-NPWT was initiated over a DRT and/or skin graft in 33 patients with 41 graft procedures. Endpoints were recorded and compared to a historical control group of 25 patients with 28 grafts bolstered with traditional rental NPWT (V.A.C.). Mean age was less for the SP-NPWT group versus the control and there were significantly more patients with peripheral vascular disease (PVD) in the SP-NPWT group compared with the control (12 versus 0, respectively). A greater number of acute wounds were present in the SP-NPWT group versus the control (26 versus 10, respectively). All other patient demographics and wound characteristics were similar. Mean follow-up time was 6.4 months for the SP-NPWT group and 12.7 months for the control group. Primary endpoint was time to hospital discharge, duration of SP-NPWT and graft take rate were collected and compared to a historical control group of patients who received traditional rental NPWT over dermal regeneration template (DRT) and/or skin grafts. Average length of inpatient hospital stay was 0 days for the SP-NPWT group and six days for the control group. The average duration of SP-NPWT post-DRT or skin graft was 5.6 days and 7.0 days for the control. This study is limited by small sample size, lack of a comparator and observer bias in estimating graft take. The authors reported that considerably more controlled research is necessary to measure efficacy of SP-NPWT in the adjunctive management of various wound types.
ciSNaP Closed Incision System (Spiracur, Sunnyvale, CA) is a single use portable, non-powered, disposable negative pressure wound therapy system that is intended for wound management through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.
The ciSNaP Closed Incision System has a sterile cartridge that provides negative pressure therapy which increases blood flow to improve wound healing. There is proprietary spring mechanism that generates consistent, even levels of pressure. A visual indicator displays when cartridge is full or discharged. Silicone wings help to approximate wound edges, reducing potential risk of dehiscence and minimizing tension on staples and sutures which is customizable in length to fit a wide range of incisions. A proprietary hydrocolloid dressing and antimicrobial gauze offer a protective barrier to minimize potential for infection and eliminate the need for dressing changes. A soft strap enables the device to be conveniently worn on the extremity or belt.
The use of the ciSNaP Closed Incision System over surgical incisions may results in:
Prevena Incision Management System is a negative pressure wound therapy (NPWT) device designed specifically for management of closed surgical incisions that continue to drain following sutured or stapled closure. The single use system consists of a negative pressure therapy unit, a canister, and dressing. The therapy unit uses three AA batteries to deliver 125 mm Hg of negative pressure to the incision site and has an eight day life. Therapy may last for a minimum of two to seven days. The therapy unit has alerts for leaks, low battery, maximum capacity and system errors. There are two dressing options Prevena Peel and Place dressing for incisions fewer than 8 inches and the Prevena Customizable dressing for incisions up to 35 inches or nonlinear. NPWT applies a localized vacuum to draw the edges of the wound together while providing a moist environment conducive to wound healing.
Singh et. al. (2018) performed a systematic review and meta-analysis to evaluate the efficacy of the Prevena System in reducing surgical site infection (SSI) in closed incisions compared to traditional dressings. The meta-analysis included 11 randomized controlled trials (RCTs), 7 prospective studies, and 12 retrospectives studies. The Prevena System showed a significant reduction in SSI (11 RCTs [n=1579];OR 2.7; 95% CI, 2.0 to 3.6; I2=24%; p<00001). Analysis of studies by anatomical location (colorectal/abdominal, obstetrics, lower extremity, groin/vascular, and cardiac) continued to demonstrate a significant effect for the Prevena System in all categories based on the fixed-effects model. When the analyses were repeated with the random-effects model, a significant effect for the Prevena System was upheld for all anatomical categories except obstetrics (OR 1.7; 95% CI, 0.9 to 3.5; p=0.11). The analysis was limited by heterogeneity in outcome reporting and blinding practices. Only 4 of 30 included studies reported on wound categories established by the Centers for Disease Control.
In 2018, Gombert et. al. published findings from the Closed Incision Negative Pressure Therapy Reduces Surgical Site Infections in Vascular Surgery (AIMS) trial, a prospective randomized controlled trial (RCT) evaluating Prevena in patients undergoing vascular groin surgery for peripheral artery disease (n=204). The primary outcome was the rate of surgical site infection (SSI) with the Prevena System (n=98) compared to patients receiving standard wound dressings (n=90). Ten patients were excluded as screening failures and 6 patients were excluded due to early occlusion of treated vessels requiring de novo surgery. The Prevena System was removed at 5-7 days postoperatively. Patients were evaluated on the day of discharge (day 7), and again at 15 and 30 days post-surgery by blinded wound care nurses. Wounds were evaluated clinically according to Szilagyi classification criteria (grades I-III). Prophylactic antibiotics were administered to 13.2% of the Prevena group and 31.1% of the control group (p=0.004). The control group experienced more frequent SSI (33.3%; 30/90) than the Prevena group (13.2%; 13/98; p=0.0015). However, the absolute risk difference of -20.1 per 100 (95% CI, -31.9 to 8.2) was based on an increased rate of Szilagyi I SSI (24.6% vs. 8.1%; p=0.0012). Bacterial swabs were performed in each case of suspected SSI. Only 10/43 suspected infections returned positive swabs, 5 in each treatment arm, suggesting the study may have been biased by methodological flaws relating to subjective SSI assessment.
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). 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.
In 2019, Hussamy et. al. reported on an open-label randomized controlled trial (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). 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).
Yu et al (2019) published a meta-analysis of prophylactic negative pressure wound therapy (NPWT) after cesarean delivery in high-risk women with obesity. Six randomized controlled trials (RCTs) and 3 cohort studies primarily utilizing Prevena and PICO systems were included for analysis. Compared to standard wound dressings, NPWT was associated with a significantly lower risk of SSI from 7 pooled studies (RR 0.45; 95% CI 0.31 to 0.66; I2=9.9%). Absolute risk reduction was -6.0% (95% CI, -10% to -3.0%) with a NNT of 17. NPWT was also associated with a statistically significant reduction in the number of composite wound complications (9 studies, RR 0.68; 95% CI 0.49 to 0.94), but no other secondary outcome measures (i.e., dehiscence, seroma, endometritis, and hospital re-admission). The analysis was limited by heterogeneity in study inclusion criteria and outcome measures, including lack of standardized definitions for surgical site infections (SSIs). Additionally, potential harms of treatment were not consistently reported across studies, whereas existing literature on the use of prophylactic NPWT in the context of other surgical procedures has reported high rates of side effects such as skin blisters, erythema, and wound bleeding. Review authors recommend larger definitive trials to clarify clinical utility.
The AVELLE negative pressure wound therapy (NPWT) system is designed to produce a continuous negative pressure of 80mmHg (+/- 20 mmHg) across the wound surface through the hydrated Hydrofiber Technology Dressing to the wound bed through 4 layers of AQUACEL Extra Dressing to a depth of 2 cm for over 7 days. It is a battery powered disposable pump with a 30 day lifetime. This NPWT system has a one way valve that helps maintain continuous pressure after removing the pump from the dressing for up to 1 hour +/- 10 mmHg, therefore, patients can keep the dressing in place by disconnecting the pump to shower.
The Hydrofiber Technology:
The AVELLE NPWT system can be used for low to moderate exuding wound types:
The myNeWT negative pressure wound therapy system is a portable, disposable, single use system for patients who have hard to heal wounds. Therapy is accomplished by the pump delivering a continuous negative pressure to the wound surface (80mm Hg +/- 20 mmHg), which draws exudate into a flexible canister, creating an environment that promotes wound healing via the removal of low to moderate amounts of exudate and infectious material from the wound. This disposable pump is battery operated and driven by a 2 AA primary lithium batteries which allows it to deliver therapy for 7 days. A sterile wound interface connects the wound dressing to the flexible canister.
The myNeWT system is indicated for patients with the following wound types:
The UNO single patient disposable negative pressure wound therapy system is battery operated and offers two options of therapy treatment time:
The UNO single patient disposable negative pressure wound therapy system has two modes of operation:
The indications for the UNO single patient disposable negative pressure wound therapy system:
The port and dressing for the UNO negative pressure wound therapy system consists of the following:
For individuals who have any wound type (acute or nonhealing) who receive portable single-use outpatient NPWT, the evidence includes systematic reviews and randomized controlled trials (RCTs). The evidence includes an RCT of the PICO Single Use Negative Pressure Wound Therapy System, an RCT of the nonpowered Smart Negative Pressure Wound Care System, and a pseudorandomized study of the Prevena Incision Management System. The PICO device was studied in an adequately powered but unblinded RCT of combined in- and outpatient use following total joint arthroplasty; also, a 2017 RCT compared the PICO device with standard dressing following abdominal surgery. Results showed some benefits, though not statistically significant. One study with the Smart Negative Pressure nonpowered Wound Care System showed noninferiority to a vacuum-assisted closure device. However, interpretation of this trial is limited by a high loss to follow-up and lack of a control group treated with dressings. These studies are insufficient to draw conclusions about its efficacy. Well-designed comparative studies with larger numbers of patients are needed to determine the effects of these technologies with greater certainty. The evidence is insufficient to determine the effects of the technology on net health outcomes.
Numerous disposable negative pressure wound therapy (NPWT) systems have received Class II clearance by the FDA through the 510(k) process.
The SNaP Wound Care System (Spiracur, Sunnyvale, CA) is a Class II device requiring notification to market but not having U.S. Food and Drug Administration (FDA) premarket approval. It received 510(k) marketing clearance from the FDA in 2009 (K081406) and is indicated for the removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
The FDA granted 510(k) Class II clearance for the PICO™ Single Use Negative Pressure Wound Therapy System (Smith and Nephew, St Petersburg, FL) on December 15, 2011. PICO was cleared as substantially equivalent to predicate devices Renasys Go (Smith & Nephew), NPD 1000 NPWT System (Kalypto Medical, Hastings, MN), and Prevena Incision Management System (KCI, San Antonio, TX). The intended use, indications and instructions for use for the subject and predicate devices are similar. According to the 510(k) clearance document, “the PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. The PICO [single-use NPWT] System is suitable for use in both a hospital and homecare setting. Examples of appropriate wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, closed surgical incisions.”
The FDA granted 510(k) Class II clearance for the V.A.C.Via™ Negative Pressure Wound Therapy System, (KCI, San Antonio, TX) on March 10, 2010. Equivalence is claimed to the KCI Acti V.A.C.™ Therapy System (KCI, San Antonio, TX). The intended use for the device states, “V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.”
The FDA granted 510(K) Class II clearance for the ciSNaP Closed Incision System (Spiracur, Sunnyvale, CA) on February 25, 2014. This is a non-powered suction apparatus device intended for negative pressure wound therapy for patients who would benefit from wound management via the application of negative pressure, particularly as the device promotes wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.
The Prevena Incision Management System was cleared for marketing in June 2010 by FDA under the 510(k) process and is intended “to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of NPWT.” The predicate device was KCI’s Acti V.A.C. (vacuum assisted closure) Therapy System. The customizable dressing was cleared for marketing in October 2012 and was designated as a combination product in March 2014.
The myNeWT Negative Pressure Wound Therapy System (Stortford Medical LLC) was cleared for marketing February 2017 by FDA under the 510(k) process and is intended to promote wound healing by removing low to moderate levels of exudate and infections materials. The appropriate wounds include: chronic wounds; acute, sub-acute and dehisced wounds; traumatic wounds; partial thickness burns, pressure or venous insufficiency ulcers, diabetic ulcers, flaps and grafts; and closed incision sites.
The AVELLE negative pressure wound therapy system (ConvaTec Limited) was cleared for marketing October 2018 by FDA under the 510(K) process and is intended to promote wound healing via removal of exudate and infectious material from low to moderately exuding wound such as: chronic wounds e.g. leg ulcers; acute wounds; subacute and dehisced wounds; traumatic wounds; flaps and graft; and surgically closed incisions sites.
The UNO negative pressure wound through system (Genadyne Biotechnologies, Inc) was cleared for marketing November 2018 by FDA under the 510(k) process and is intended to promote wound healing by the removal of low to moderate exudates and infectious material from the following wound types: chronic; acute; traumatic; subacute and dehisced wounds; partial thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; and closed surgical incision.
This policy applies to the use of non-powered negative pressure wound therapy (NPWT) systems (mechanical or single use (disposable) battery operated devices) in the outpatient setting.
The use of non-powered negative pressure wound therapy (NPWT) system devices (mechanical) or single use (disposable) battery operated negative pressure wound therapy system devices including but not limited to the following, are considered investigational for all indications:
For individuals who have any wound type (acute or nonhealing) who receive non-powered negative pressure wound therapy (NPWT) (mechanical) or single use (disposable) battery operated negative pressure wound therapy, the evidence includes systematic reviews and randomized controlled trials (RCTs). These studies are insufficient to draw conclusions about their efficacy. Well-designed comparative studies with larger numbers of patients are needed to determine the effects of these technologies with greater certainty. The evidence is insufficient to determine the effects of the technology on net health outcomes.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
O'Leary DP, Peirce C, Anglim B, et al. Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: The P.I.C.O. Trial. Ann Surg. Jun 2017;265(6):1082-1086. PMID 27926575
Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. PMID: 28885895
Grauhan O, Navasardyan A, Hofmann M, et al. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. May 2013;145(5):1387-1392. PMID 23111014
Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. Oct 2016;13(5):663-667. PMID 25125244
Gombert A, Babilon M, Barbati ME, et al. Closed Incision Negative Pressure Therapy Reduces Surgical Site Infections in Vascular Surgery: A Prospective Randomised Trial (AIMS Trial). Eur J Vasc Endovasc Surg. 2018 Sep;56(3):442-448. PMID: 29970335
Murphy PB, Knowles S, Chadi SA, et al. Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann. Surg. 2019 Jul;270(1). PMID 30499799
Hussamy DJ, Wortman AC, McIntire DD, et al. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4). PMID 31503147
Singh DP, Gabriel A, Parvizi J, et al. Meta-Analysis of Comparative Trials Evaluating a Single-Use Closed-Incision Negative-Pressure Therapy System. Plast Reconstr Surg. 2019 Jan;143:41S-46S. PMID: 30586103
Yu L, Kronen RJ, Simon LE, et al. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2):200-210.e1. PMID: 28951263
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