A Randomized Control Trial for Preventative Scar Management
NCT ID: NCT01602458
Last Updated: 2019-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2011-05-31
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Pressure Garments for Burn Scars
NCT00675974
Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment
NCT03628495
Fractional CO2 Laser Treatment of Hypertrophic Scars
NCT04236167
Effectiveness of Pressure Garment Therapy After Burns
NCT01005732
The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
NCT03469830
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Silicone Only Therapy (SOT)
Mepiform™ silicone will be utilized by SOT group.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seton Healthcare Family
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adam Weinfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Dell Children's Medical Center Rehabilitation Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR-10-134
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.