Clinical trial NCT03416660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keywords: Fractional laser
Postburn scar
Density
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Clinical improvement Vancouver score
timeFrame: 1 month after last session
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Souzan Mohamed Amin
state: القاهرة
Study officials:
affiliation: Cairo University
name: SOUZAN M AMIN
role: PRINCIPAL_INVESTIGATOR
References: