A Randomized Control Trial for Preventative Scar Management
The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 20, 2019
May 1, 2019
2.5 years
May 10, 2012
May 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Scar Management Research Intake Form
Baseline through 24 weeks
Patient Compliance Log (PCL)
Baseline through 24 weeks
Photographs
Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24
Study Arms (2)
Silicone Only Therapy (SOT)
OTHERMepiform™ silicone will be utilized by SOT group.
Silicone Pressure Garment Therapy (SPGT)
OTHERMepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dell Children's Medical Center of Central Texas
Austin, Texas, 78798, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Weinfeld, MD
Dell Children's Medical Center Rehabilitation Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 21, 2012
Study Start
May 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 20, 2019
Record last verified: 2019-05