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临床试验/NCT03416660
NCT03416660已完成不适用

Comparison Between Effectiveness of Different Densities of Fractional Carbon Dioxide Laser in Treatment of Postburn Scar.

Cairo University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Clinical improvement Vancouver score

研究概览

简要总结

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

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

masked to the parameters of laser treatment in each lesion

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

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

研究组 & 干预措施

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).

干预措施: Fractional Carbon Dioxide laser (Device)

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).

干预措施: Fractional Carbon Dioxide laser (Device)

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).

干预措施: Fractional Carbon Dioxide laser (Device)

结局指标

主要结局

Clinical improvement Vancouver score

时间窗: 1 month after last session

to compare the efficacy of different densities of fractional laser in treatment of post burn scars

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzan Shalaby

Principal investigator

Cairo University

研究点 (2)

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