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A Randomized Control Trial for Preventative Scar Management

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT01602458
First received: May 10, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Hypertrophic Scarring
 Procedure: Silicone Only Therapy (SOT)
Procedure: Silicone Pressure Garment Therapy (SPGT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Seton Family of Hospitals:

Primary Outcome Measures:
  • Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Vancouver Scar Scale (VSS) [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.


Secondary Outcome Measures:
  • Scar Management Research Intake Form [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Compliance Log (PCL) [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
    Patients will be given a daily log to record hours of compliance with intervention.

  • Photographs [ Time Frame: Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602458

Locations
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78798
Sponsors and Collaborators
Seton Family of Hospitals
Investigators
Principal Investigator: Adam Weinfeld, MD Dell Children's Medical Center Rehabilitation Department
  More Information

No publications provided

Responsible Party: Seton Family of Hospitals
ClinicalTrials.gov Identifier: NCT01602458     History of Changes
Other Study ID Numbers: CR-10-134
Study First Received: May 10, 2012
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seton Family of Hospitals:
Preventative Scar Management
Skin Grafts
Silicone Therapy
Silicone Pressure Garment Therapy

Additional relevant MeSH terms:
Cicatrix
Hypertrophy
Cicatrix, Hypertrophic
 Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013