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The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
The goals of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone Only Therapy (SOT) | Other | Mepiform™ silicone will be utilized by SOT group. |
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| Silicone Pressure Garment Therapy (SPGT) | Other | Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone Only Therapy (SOT) | Procedure | SOT group will be instructed to wear the silicone for 23 hours/day, removing only for bathing. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. Compression free medical tape will be used to secure the silicone in place. Patients will be provided with 6 months of topical silicone therapy. If optimal results are achieved prior to 6 months of therapy, the treatment will be discontinued. Patients will also be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Observer Scar Assessment Scale (POSAS) | This scale incorporates the patient's/caregiver's perspective on their scar. It measures scar color, pliability, thickness, relief, itching, and pain scored by patient/caregiver. The observer scale measures vascularization, pigmentation, pliability, thickness, and relief. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Vancouver Scar Scale (VSS) | This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Management Research Intake Form | This form will include date of enrollment, randomization to group, age, race, gender, date of injury, type of injury, location of injury, type of graft, graft dimensions, date of surgery, date graft healed, number of days for graft to heal, date silicone started, date garment issued, and date silicone/garment discontinued. | Baseline through 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Weinfeld, MD | Dell Children's Medical Center Rehabilitation Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78798 | United States |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Silicone Pressure Garment Therapy (SPGT) | Procedure | SPGT group will be instructed to use the Mepiform™ silicone only for 2 weeks during the interim before final fitting with the custom compression garment. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. The patients will be instructed to wear the silicone for 23 hours/day, removing only for bathing. The patient will continue to use the Mepiform™ silicone under the compression garment for the entire length of the study. The garment will be replaced after 3 months of wear, in order to ensure that optimal pressure and silicone management is applied to the area. Patients will be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone and Compression Garment. |
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| Patient Compliance Log (PCL) | Patients will be given a daily log to record hours of compliance with intervention. | Baseline through 24 weeks |
| Photographs | The Physical/Occupational Therapists are to obtain de-identifiable photographs of the graft site at each visit, in order to have visual documentation of the wound healing process throughout the duration of the study. | Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24 |