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

NCT ID: NCT03416660

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-12-23

Brief Summary

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

Detailed Description

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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 .

Conditions

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Scar

Keywords

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Fractional laser Postburn scar Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
masked to the parameters of laser treatment in each lesion

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Fractional Carbon Dioxide laser

Intervention Type DEVICE

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).

Group Type ACTIVE_COMPARATOR

Fractional Carbon Dioxide laser

Intervention Type DEVICE

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).

Group Type ACTIVE_COMPARATOR

Fractional Carbon Dioxide laser

Intervention Type DEVICE

Interventions

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Fractional Carbon Dioxide laser

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Suzan Shalaby

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SOUZAN M AMIN

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Souzan Mohamed Amin

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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cairou19

Identifier Type: -

Identifier Source: org_study_id