Burn Garments

Number: 0062

Policy

Aetna considers burn garments and associated physical and occupational therapy medically necessary when all of the following criteria are met:

• The burn is of documented significance to place the member at risk of a post-burn contracture; and
• The burn garment and physical and occupational therapies are being used with the intent of preventing the need for skin grafting or contractures as a result of hypertrophic scarring; and
• The burn garment is authorized by the primary care physician and/or the treating specialist.

Aetna considers the use of support garments for scar minimization of the donor site experimental and investigational because their effectiveness for this indication has not been established.

Note: Burn garments, such as inflatable compression garments used with a pump to apply controlled pressure to stimulate circulation, are considered durable medical equipment (DME).  Please check benefit plan descriptions for details on DME coverage.

Background

Burn patients frequently require prolonged follow-up care after injury.  Follow-up is typically done as an outpatient to a burn clinic where the patient is seen by a burn therapist.  Positioning, splinting, exercise, and pressure garments help preserve function and appearance as burn wounds heal.  Body surfaces with high skin tension and movement (e.g., chest, face, hands, joints, and upper legs) are most susceptible to scarring and contractures.  Follow-up visits are initially scheduled 7 to 14 days after discharge, and then every 1 to 2 weeks for the next 2 months, finally every month for about 3 months, and then every 3 months until their hypertrophic scar matures and they no longer need compression garments (usually a period of 12 months).

1.  to conduct a systematic review to identify the available evidence for the use of pressure garment therapy (PGT);
2. to assess the quality of the available evidence; and
3. to conduct a meta-analysis to quantify the effectiveness of PGT for the prevention of abnormal scarring following burn. 

Randomized control trials were identified from CINHAL, EMBASE, MEDLINE, CENTRAL, the "grey literature" and hand searching of the Proceedings of the American Burn Association. Primary authors and pressure garment manufacturers were contacted to identify eligible trials.  Bibliographies from included studies and reviews were searched.  Study results were pooled to yield weighted mean differences (WMD) or standardized mean difference (SMD) and reported using 95 % confidence intervals (CIs).  The review incorporated 6 unique trials involving 316 patients.  Original data from 1 unpublished trial were included.  Overall, studies were considered to be of high methodological quality.  The meta-analysis was unable to demonstrate a difference between global assessments of PGT-treated scars and control scars (WMD: -0.46; 95 % CI: -1.07 to 0.16).  The meta-analysis for scar height showed a small, but statistically significant, decrease in height for the PGT-treated group (SMD: -0.31; 95 % CI: -0.63 to 0.00).  Results of meta-analyses of secondary outcome measures of scar vascularity, pliability and color failed to show a difference between groups.  The authors concluded that PGT does not appear to alter global scar scores.  It does appear to improve scar height, although this difference is small and of questionable clinical importance.  The beneficial effects of PGT remain unproven, while the potential morbidity and cost are not insignificant.  Given current evidence, additional research is needed to ascertain the effectiveness, risks and costs of PGT.

There is a lack of evidence that pressure garments and silicone sheeting result in improved outcomes compared to pressure garments alone.  In a pilot study, Harte et al (2009) examined if pressure and silicone therapy used simultaneously are more effective in treating multiple characteristics of hypertrophic scars than pressure alone.  A total of 22 subjects with hypertrophic burn scars were randomized to receive Jobskin pressure garments and Mepiform silicone sheeting or Jobskin pressure garments alone.  The Vancouver Scar Scale (VSS) was used to measure multiple scar characteristics at baseline, week 12, and week 24.  No statistically significant difference was found in the rate of change of the VSS scores between the pressure therapy (PT) group and the PT plus silicone group at week 12 or week 24; however, the mean scores of both groups decreased over 24 weeks.  There were no statistically significant changes in the VSS subscores (pigmentation, pliability, scar height, and vascularity) from baseline to week 12 or week 24.  A statistically significant relationship was observed between the VSS score and total burn surface area (less than 30 %) in the PT group at baseline (p < 0.05), over 12 weeks (p < 0.05), and over 24 weeks (p < 0.05).  The authors noted that given the limitations of this study, especially the small sample size, further research is needed before any firm conclusions can be drawn on this therapy approach.  However, this pilot study has discussed the recurring issues in the research regarding these controversial treatments and has yielded potential for further investigation in a fully powered randomized controlled trial.

Atiyeh and associates (2013) noted that hypertrophic burn scars pose a challenge for burn survivors and providers.  In many cases, they can severely limit a burn survivor's level of function, including work and recreational activities.  A widespread modality of prevention and treatment of hypertrophic scarring is the utilization of pressure garment therapy (PGT).  Despite the magnitude of the problem of hypertrophic scarring and the ubiquitous use of PGT, strong clinical evidence of the effectiveness of PGT in the literature is lacking.  Some of the challenges facing measurement of the effectiveness of PGT on hypertrophic scarring are lack of clear definitions for degree of hypertrophic scarring, inability to quantify pressure applied to scars, patient non-compliance to strict PGT time schedules, as well as the inability to conduct randomized controlled trials (RCTs) comparing PGT to no therapy for ethical reasons since PGT is considered a standard of care.

Scar Minimization of the Donor Site:

Donovan and colleagues (2016) stated that PGT is well accepted and commonly used by clinicians in the treatment of burns scars and grafts.  The medium to high pressures (24 to 40 mmHg) in these garments can support scar minimization, and evidence is well-documented for this particular application.  However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well-documented.  This study protocol investigates the impact of a low pressure (4 to 6 mmHg) interim garment on donor site healing and scarring.  With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been 2-fold.  Interim pressure garments for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management.  However, anecdotal and observational evidence suggested that IPGs also made a difference to some patient's scar outcomes for donor sites.  This study protocol outlines a RCT designed to test the effectiveness of this treatment on reducing scarring to burn donor sites.  This study is a single-center, single (assessor)-blinded, RCT in patients with burns donor sites to their thighs.  Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment.  Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days).  The IPG treatment will be administered post-operatively (on day 5).  Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months.  This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars.  Such therapy specifically for donor scar management is poorly represented in the literature.  This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh.  The authors noted that no known studies of this nature have been carried out to-date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimization.

The above policy is based on the following references: