A Randomized Control Trial for Preventative Scar Management

Not Applicable

Completed

• Conditions: Hypertrophic Scarring
• Interventions: Procedure: Silicone Pressure Garment Therapy (SPGT); Procedure: Silicone Only Therapy (SOT)

• Registration Number: NCT01602458
• Lead Sponsor: Seton Healthcare Family

Brief Summary

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.

Detailed Description

The goals of this study are to:

1. Examine the difference between patient scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.

2. Examine the difference between observer scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.

3. Examine the difference between Vancouver scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.

4. Examine the need for surgical intervention in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• patients who have undergone surgery within one month prior to enrollment
• patient must have a split-thickness or full thickness skin graft with extremity involvement secondary to a traumatic skin injury (burn, laceration, avulsion or de-gloving type injury) that has healed (based on clinician assessment of wound healing)
• patients with comorbid conditions
• patients must be referred to and attend scar management clinic at DCMC

Exclusion Criteria

• patients with concave scars at the site of the skin graft
• patients with skin graft scars larger than 4x7 inches
• patients with presence of current skin infection or history of dermatological condition such as eczema
• patients with skin grafts only on parts of the body other than extremities
• patients with reported silicone allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone Pressure Garment Therapy (SPGT)	Silicone Pressure Garment Therapy (SPGT)	Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group.
Silicone Only Therapy (SOT)	Silicone Only Therapy (SOT)	Mepiform™ silicone will be utilized by SOT group.

Primary Outcome Measures

Name	Time	Method
Vancouver Scar Scale (VSS)	Baseline, 8 weeks, 16 weeks, and 24 weeks	This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.
Patient Observer Scar Assessment Scale (POSAS)	Baseline, 8 weeks, 16 weeks, and 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Photographs	Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24	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.
Patient Compliance Log (PCL)	Baseline through 24 weeks	Patients will be given a daily log to record hours of compliance with intervention.
Scar Management Research Intake Form	Baseline through 24 weeks	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.

Trial Locations

Locations (1)

Dell Children's Medical Center of Central Texas; 🇺🇸 Austin, Texas, United States