跳至主要内容
临床试验/NCT02063243
NCT02063243已完成不适用

Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars

Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Recurrence

研究概览

简要总结

This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients

详细描述

Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a population consisting of all Fitzpatrick skin type patients.

Multiple devices are available, mostly based on a simple open system. Closed, argon gas based, systems are highly controlled and provide accurate freezing. However, this technique has never been used for IL cryotherapy for the treatment of keloid or hypertrophic scars. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a argon based device called Seednet. Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.

研究设计

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

入排标准

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

入选标准

  • Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
  • Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
  • A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
  • Patients with all Fitzpatrick17 skin types
  • Patients older than 10 years of age

排除标准

  • pregnancy
  • diabetes mellitus

结局指标

主要结局

Recurrence

时间窗: 0-12 months

Judgment of recurrence, defined as a growing, pruritic, nodular scar

次要结局

  • Scar elasticity(0-12months)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michiel van Leeuwen

MD

Amsterdam UMC, location VUmc

研究点 (2)

Loading locations...

相似试验