Clinical trial NCT01602458: A Randomized Control Trial for Preventative Scar Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scarring
Keywords: Preventative Scar Management
Skin Grafts
Silicone Therapy
Silicone Pressure Garment Therapy
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Observer Scar Assessment Scale (POSAS)
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
measure: Vancouver Scar Scale (VSS)
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary outcomes:
measure: Scar Management Research Intake Form
timeFrame: Baseline through 24 weeks
measure: Patient Compliance Log (PCL)
timeFrame: Baseline through 24 weeks
measure: Photographs
timeFrame: Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
affiliation: Dell Children's Medical Center Rehabilitation Department
name: Adam Weinfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: