A Randomized Control Trial for Preventative Scar Management



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:1 - 18
Updated:3/30/2013
Start Date:May 2011
End Date:January 2014
Contact:Jill Meredith, RN
Email:JRMeredith@Seton.org
Phone:(512) 324-9999

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


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:

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.

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
We found this trial at
1
site
4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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Austin, TX
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