Medical Policy: 01.01.20
Original Effective Date: September 2012
Reviewed: April 2018
Revised: April 2018
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.
Negative pressure wound therapy (NPWT) consists of 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 of these 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 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: chronic wounds; acute wounds; traumatic wounds; subacute and dehisced wounds; partial thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; closed surgical incisions.
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.
Based on review of the literature there is one randomized controlled trial (RCT) and five nonrandomized studies, the studies suggest that patients experienced fewer postoperative wound related problems if they received the Prevena Incision Management System. However, confounders (bias) prevent drawing strong conclusions from this evidence. Further well designed comparative studies with larger numbers of patients are needed.
For individuals who have any wound type (acute or non-healing) who receive portable single-use outpatient negative pressure wound therapy, the evidence does include randomized clinical trials (RCTs). The evidence includes an RCT of the PICO single use negative pressure wound therapy system, and RCT of the non-powered Smart Negative Pressure (SNaP) Would 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. Results showed some benefits that approached statistical significance. Further studies in an outpatient setting are needed. One study with SNaP non-powered wound care system showed non-inferiority to a vacuum assisted closure device. However, interpretation of this trial is limited by a high loss to follow-up and lack of 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 the technology with greater certainty. The evidence is insufficient to determine the effects of the technology on net health outcomes.
Numerous disposable negative pressure wound therapy 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 devie 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.
This policy applies to the use of non-powered negative pressure wound therapy (NPWT) systems in the outpatient setting.
The use of non-powered negative pressure wound therapy (NPWT) system devices (non-electrically powered NPWT (mechanical); single use (disposable) battery operated, including but not limited to the following, is considered investigational for the treatment of all indications:
Based on review of the published peer reviewed medical literature the available studies addressing disposable non-powered mechanical or singe use non-electrically powered negative pressure wound therapy (NPWT) devices is generally limited by small sample size and a lack of a comparator and therefore, conclusions about the safety, efficacy and net health outcomes cannot be established at this time. Further well designed comparative studies with larger number of patients are needed to determine the effects of this technology on net health outcomes. The evidence is insufficient to determine the effects of the technology on net health outcomes.
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