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临床试验/NCT00548210
NCT00548210Unknown不适用

Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.

Association of Dutch Burn Centres1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年10月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1

研究概览

简要总结

The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

详细描述

The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited.

Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations.

Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars.

Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
  • Written informed consent
  • Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
  • Patients of 18 years or older
  • Exclusion criteria:
  • Known sensitivity for occlusive dressings or silicone containing products
  • Any patient condition that may influence the compliance of the treatment negatively.

排除标准

  • 未提供

研究者

发起方
Association of Dutch Burn Centres
申办方类型
Other

研究点 (1)

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