A Randomized Control Trial for Preventative Scar Management

Seton Healthcare Family

Status

Completed

Conditions

Hypertrophic Scarring

Treatments

Procedure: Silicone Only Therapy (SOT)

Procedure: Silicone Pressure Garment Therapy (SPGT)

Study type

Interventional

Funder types

Other

Identifiers

NCT01602458

CR-10-134

Details and patient eligibility

About

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.

Full description

The goals of this study are to:

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.
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.
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.
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.

Enrollment

12 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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