Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Medstar Health Research Institute
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
Overview
Brief Summary
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars.
This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age
- •At least 1 second or third degree burn wound that required treatment with split-thickness skin grafts
- •Donor site with at least a 4 x 4 inch surface area
- •Able to return to clinical site for treatments and assessments of burn injuries
Exclusion Criteria
- •Pregnancy or nursing
- •Oral retinoid medication use within the past 6 months
- •Medical history of Ehlers-Danlos syndrome, AIDS
- •Nutritional deficiencies in the opinion of the investigator that would affect wound healing
- •Wounds complicated by clinically significant infection within past 30 days
Outcomes
Primary Outcomes
Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
Time Frame: 2 months
The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment. The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.
Secondary Outcomes
No secondary outcomes reported