Clinical Trial: A Randomized Control Trial for Preventative Scar Management

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management

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 Summary:

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.

Sponsor: Seton Healthcare Family

Current Primary Outcome:

  • Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: 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.
  • Vancouver Scar Scale (VSS) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Scar Management Research Intake Form [ Time Frame: 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.
  • Patient Compliance Log (PCL) [ Time Frame: Baseline through 24 weeks ]
    Patients will be given a daily log to record hours of compliance with intervention.
  • Photographs [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Seton Healthcare Family

Dates:
Date Received: May 10, 2012
Date Started: May 2011
Date Completion:
Last Updated: May 13, 2014
Last Verified: May 2014