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临床试验/NCT01005992
NCT01005992Unknown1 期

Fractional Photothermolysis for the Treatment of Burn Scars

Clinica las Condes, Chile1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
10
试验地点
1
主要终点
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.

研究概览

简要总结

The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.

详细描述

One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.

Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.

The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
  • The scar should be slightly elevated, with erythema and with no signs of keloid formation.
  • Maximum scar dimension: 0.2 - 1% body surface area.
  • Acceptance of informed consent for laser treatment.

排除标准

  • Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
  • Previous surgical treatment (i.e. graft)

结局指标

主要结局

Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.

时间窗: 5 months

Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation

时间窗: 5 months

次要结局

  • Change in surface area and perimeter of burn scar(5 months)
  • Tissue pliability, elevation and flexibility with a digital piedemeter(5 months)
  • Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.(5 months)

研究者

发起方
Clinica las Condes, Chile
申办方类型
Other

研究点 (1)

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