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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scarring
• Intervention / Treatment: Procedure: Silicone Only Therapy (SOT); Procedure: Silicone Pressure Garment Therapy (SPGT)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78798
      • Dell Children's Medical Center of Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Silicone Only Therapy (SOT); Mepiform™ silicone will be utilized by SOT group.	Procedure: Silicone Only Therapy (SOT); 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.
OTHER: Silicone Pressure Garment Therapy (SPGT); Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group.	Procedure: Silicone Pressure Garment Therapy (SPGT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Management Research Intake Form	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.	Baseline through 24 weeks
Patient Compliance Log (PCL)	Patients will be given a daily log to record hours of compliance with intervention.	Baseline through 24 weeks
Photographs	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.	Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24

Collaborators and Investigators

• Sponsor: Seton Healthcare Family
• Investigators: Principal Investigator: Adam Weinfeld, MD, Dell Children's Medical Center Rehabilitation Department

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (ESTIMATE): May 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Skin Grafts; Preventative Scar Management; Silicone Therapy; Silicone Pressure Garment Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: CR-10-134