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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03416660
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Suzan Shalaby, Cairo University

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

Condition or disease Intervention/treatment Phase
Scar Device: Fractional Carbon Dioxide laser Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: masked to the parameters of laser treatment in each lesion
Primary Purpose: Treatment
Official Title: Comparison Between Effectiveness of Different Densities of Fractional Carbon Dioxide Laser in Treatment of Postburn Scar.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Low density
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
Active Comparator: Medium 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).
Device: Fractional Carbon Dioxide laser
Active Comparator: High 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).
Device: Fractional Carbon Dioxide laser



Primary Outcome Measures :
  1. Clinical improvement Vancouver score [ Time Frame: 1 month after last session ]
    to compare the efficacy of different densities of fractional laser in treatment of post burn scars



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416660


Locations
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Egypt
Souzan Mohamed Amin
Cairo, القاهرة, Egypt, 11562
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: SOUZAN M AMIN Cairo University

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Responsible Party: Suzan Shalaby, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03416660     History of Changes
Other Study ID Numbers: cairou19
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Suzan Shalaby, Cairo University:
Fractional laser
Postburn scar
Density