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

Not Applicable

Completed

• Conditions: Scar
• Interventions: Device: Fractional Carbon Dioxide laser

• Registration Number: NCT03416660
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-23
• Status Verified: 2018-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-24
• Study First Posted: 2018-01-31
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

• • Pregnancy.

  • Lactation.
  • Oral retinoid drugs within the past 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium density	Fractional Carbon Dioxide laser	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).
High density	Fractional Carbon Dioxide laser	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).
Low density	Fractional Carbon Dioxide laser	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).

Primary Outcome Measures

Name	Time	Method
Clinical improvement Vancouver score	1 month after last session	to compare the efficacy of different densities of fractional laser in treatment of post burn scars

Trial Locations

Locations (1)

Souzan Mohamed Amin; 🇪🇬 Cairo, القاهرة, Egypt