Efficacy of Different Densities of Fractional Carbon Dioxide in Treatment of Post Burn Scars

Study Overview
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Brief Summary
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This study aims to compare effectiveness of different densities of carbon dioxide fractional laser in the treatment of postburn scar.

Detailed Description
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The study included 25 Egyptian patients with burn scars recruited from the Out Patient Clinic, Dermatology Department, Cairo University. Each has three post burn scars, assigned to monthly fractional Carbon dioxide laser sessions with a total of 3 sessions. parameters are : Lesion A or part A parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 900µm spacing (7.4% density). Lesion B or part B parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 600µm spacing (12.6% density). Lesion C or part C parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 300 µm spacing (25.6% density). 3 mm punch biopsy is taken before and one month after last session for assessment of collagen via (Masson's trichrome strain). In addition clinical evaluation is done via Vancouver & Patient and Observer Scar Assessment Scale .

Official Title
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Comparison Between Effectiveness of Different Densities of Fractional Carbon Dioxide Laser in Treatment of Postburn Scar.

Conditions
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Scar

Intervention / Treatment
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* Device: Fractional Carbon Dioxide laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Burn scars of at least 1 year duration. Patients with three separate lesions each of them about 2 to 5cm or patients with single lesion equal or more than 8 to 10cm. Exclusion Criteria: • Pregnancy. Lactation. Oral retinoid drugs within the past 6 months.

Ages Eligible for Study
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Minimum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study included 25 Egyptian patients with burn scars recruited from the Out Patient Clinic, Dermatology Department, Cairo University. Each has three post burn scars, assigned to monthly fractional carbon dioxide laser sessions with a total of 3 sessions. parameters are : Lesion A or part A parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 900µm spacing (7.4% density). Lesion B or part B parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 600µm spacing (12.6% density). Lesion C or part C parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 300 µm spacing (25.6% density). 3 mm punch biopsy is taken before and one month after last session for assessment of collagen via (Masson's trichrome strain). In addition clinical evaluation is done via Vancouver & Patient and Observer Scar Assessment Scale
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low density<br>Fractional carbon dioxide laser: Lesion A or part A parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 900µm spacing (7.4% density). | Device: Fractional Carbon Dioxide laser<br> <br> |
| Active Comparator: Medium density<br>Fractional carbon dioxide laser : Lesion B or part B parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 600µm spacing (12.6% density). | Device: Fractional Carbon Dioxide laser<br> <br> |
| Active Comparator: High density<br>Fractional carbon dioxide laser : Lesion C or part C parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 300 µm spacing (25.6% density). | Device: Fractional Carbon Dioxide laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement Vancouver score | to compare the efficacy of different densities of fractional laser in treatment of post burn scars | 1 month after last session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Density, Fractional laser, Postburn scar