Study of Silicone Material Inserts To Treat Burn Scars

Study Overview
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Brief Summary
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The purpose of this study is to determine if the use of silicone material inserts within pressure garments is effective in decreasing hypertrophic burn scar formation as compared to standard pressure garment therapy.

Detailed Description
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Surgical revision, potential hospitalization, and extensive post-surgical rehabilitation may be required for the revision and correction of hypertrophic burn scars to restore function and prevent disability. This in turn results in an increased financial burden to the medical system. More importantly, the patient is required to undergo an additional invasive medical procedure that can potentially create further hypertrophic scarring. Prevention and reduction of hypertrophic scars with non-invasive, cost effective, and evidence based treatment modalities is therefore the most desirable approach. Two of the most generally accepted methods of non-invasive treatment, pressure garments and silicone gel sheeting, have been demonstrated to individually treat hypertrophic scarring. Recently, burn therapists have begun to use silicone bonded material inserts within pressure garments following the logical deduction that the two therapeutic techniques can be combined to resolve many of the cited individual disadvantages, while reaping the benefits of each individual modality. It is the aim of this study to determine the efficacy of these silicone bonded material inserts within pressure garments in the treatment of hypertrophic scarring.

Official Title
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Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars

Conditions
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Burns

Intervention / Treatment
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* Device: Pressure garment and silicone insert
* Device: Pressure garment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who would normally receive pressure garments presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft Minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf Between 16 years and 60 years of age Patient must consent to the study or obtain consent from guardian if <18 years of age Must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment Exclusion Criteria: Presence of pre-existing hypertrophic or keloid scarring Pressure garments initiated greater than 2 months post discharge from hospital Pre-existing decrease in range of motion of affected extremity One treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area Patient unable to comprehend or participate in self reporting

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure garment and silicone insert<br>Custom measured pressure garment with a textile bonded silicone insert in either the distal or proximal portion of the pressure garment, to be worn 23 hours per day. | Device: Pressure garment and silicone insert<br>* Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.<br>|
| Active Comparator: Pressure Garment<br>Custom measured pressure garment, to be worn 23 hours per day. | Device: Pressure garment<br>* Custom made fabric pressure garment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar pliability measured in gm/mm squared | The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale. Because the MVSS is a subjective rating system, we will also be using the NK Skin Compliance Device (SCD)to measure scar pliability. It is a non-invasive hand-held device that measures skin compliance or pliability. | A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar vascularity | The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale. | A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic scarring, Silicone Material, Pressure garments