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

Primary Purpose

Scar

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional Carbon Dioxide laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Fractional laser, Postburn scar, Density

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Souzan Mohamed Amin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low density

Medium density

High density

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Clinical improvement Vancouver score
to compare the efficacy of different densities of fractional laser in treatment of post burn scars

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
January 24, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03416660
Brief Title
Efficacy of Different Densities of Fractional Carbon Dioxide in Treatment of Post Burn Scars
Official Title
Comparison Between Effectiveness of Different Densities of Fractional Carbon Dioxide Laser in Treatment of Postburn Scar.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Fractional laser, Postburn scar, Density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
masked to the parameters of laser treatment in each lesion
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low density
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Medium density
Arm Type
Active Comparator
Arm Description
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).
Arm Title
High density
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Fractional Carbon Dioxide laser
Primary Outcome Measure Information:
Title
Clinical improvement Vancouver score
Description
to compare the efficacy of different densities of fractional laser in treatment of post burn scars
Time Frame
1 month after last session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SOUZAN M AMIN
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Souzan Mohamed Amin
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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