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

NCT03416660 | Completed

• 1 other identifier: cairou19
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scar

Keywords

Fractional laser; Postburn scar; Density

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Low density

ACTIVE COMPARATOR

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

Medium density

ACTIVE COMPARATOR

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

High density

ACTIVE COMPARATOR

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

Interventions

Fractional Carbon Dioxide laser DEVICE

High density; Low density; Medium density

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Souzan Mohamed Amin

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• SOUZAN M AMIN

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: masked to the parameters of laser treatment in each lesion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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 Record Dates

• First Submitted: January 12, 2018
• First Posted: January 31, 2018
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 23, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)