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.

Moiemen and colleagues (2018) noted that 11 million people suffer a fire-related injury worldwide every year, and 71 % have significant scarring; and PGT is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness.  These researchers identified the barriers to, and the facilitators of, conducting a RCT of burn scar management with and without PGT and tested whether or not such a trial is feasible.  Design of the study included web-based surveys, semi-structured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation; setting was at the United Kingdom National Health Service (UK-NHS) burns services. Interviews and the pilot trial were run in 7 burns services.  A total of 30 NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews.  Face-to-face interviews were held with 24 adult patients and 16 parents of pediatric patients who had undergone PGT.  The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy.  Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with 8 staff from 6 sites at the end of the trial.  The intervention was standard care with pressure garments.  The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage 3 or 4 times per day with moisturizer, silicone treatment, stretching and other exercises.  Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments.  The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery.  The UK-NHS burns services treated 2,845 patients per annum (1,476 pediatric and 1,369 adult) and use pressure garments for 6 to 18 months, costing £2,171,184.  The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment.  Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT.  A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden.  The outcome tools evaluated in the pilot trial did not cover all of these domains.  The planned 88 participants were recruited: the eligibility rate was 88 % [95 % CI: 83 % to 92 %], the consent rate was 47 % (95 % CI: 40 % to 55 %); 5 (6 %) participants withdrew, 14 (16 %) were lost to follow-up and 8 (9 %) crossed-over.  Adherence was as in clinical practice.  Completion of outcomes was high for adult patients but poorer from parents of pediatric patients, particularly for quality of life (QOL).  Sections on range of movement and willingness to pay were found to be challenging and poorly completed.  The authors concluded that a definitive RCT of PGT in burn scar management appeared feasible.  However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are needed.  The authors noted that the main limitation of this study was the Brisbane Burn Scar Impact Profile appeared more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study.

DeBruler and associates (2018) stated that PGT is often prescribed to improve scar properties following full-thickness burn injuries; and PGT is generally recommended for long periods of time following injury (1 to 2 years), though it is plagued by extremely low patient compliance.  These researchers examined the effects of early cessation of PGT on scar properties.  Full-thickness burn injuries were created along the dorsum of red Duroc pigs.  The burn eschar was excised and wound sites autografted with split-thickness skin.  Scars were treated with pressure garments within 1 week of injury and pressure was maintained for either 29 weeks (continuous pressure) or for 17 weeks followed by cessation of pressure for an additional 12 weeks (pressure released); scars receiving no treatment served as controls.  Scars that underwent PGT were significantly smoother and less contracted with decreased scar height compared to control scars at 17 weeks.  These benefits were maintained in the continuous pressure group until week 29.  In the pressure released group, grafts significantly contracted and became more raised, harder and rougher after the therapy was discontinued.  Pressure cessation also resulted in large changes in collagen fiber orientation and increases in collagen fiber thickness.  The authors concluded that these findings suggested that PGT effectively improved scar properties following severe burn injury; however, early cessation of PGT resulted in substantial loss of these improvements.  These investigators stated that these changes in scar properties after pressure cessation support the need to continue PGT for greater lengths of time; additional studies are needed to determine the duration of PGT required to achieve maximum benefit without regression after pressure removal.

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: