Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars
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
- 否
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
Michiel van Leeuwen
MD
Amsterdam UMC, location VUmc
