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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416660
• Other study ID #: cairou19
• Status: Completed
• Phase: N/A
• First received: January 12, 2018
• Last updated: January 24, 2018
• Start date: July 1, 2016
• Est. completion date: December 23, 2017

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 23, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scar

Intervention

Device:
• Fractional Carbon Dioxide laser

Locations

Country	Name	City	State
Egypt	Souzan Mohamed Amin	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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