CO2 Laser Revision for Burn Related Donor Site Scars

Study Overview
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Brief Summary
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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).

Official Title
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Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial

Conditions
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Burn Scar, Scar, Skin Graft Scar

Intervention / Treatment
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* Procedure: Fractional CO2 Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-subject comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Scar section does not receive CO2 laser therapy. | |
| Experimental: Factional CO2<br>Scar section receives fractional CO2 laser therapy. | Procedure: Fractional CO2 Laser<br>* The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments | 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser