NCT03312166已完成不适用
First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery
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
- 31
- 试验地点
- 1
- 主要终点
- Recurrence of keloid scar
研究概览
简要总结
SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 yo;
- •Patient with aer lobe keloid;
- •Patient with an indication of reconstructive surgery;
- •Signature of informed consent from the patient;
- •Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study;
- •Patient with French social insurance.
排除标准
- •Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality);
- •Patient with know nickel allergy;
- •Patient with know silicon allergy;
- •Pregnant women;
- •Legal incapacity or limited legal capacity;
- •Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator;
- •Patient without health insurance;
- •The patient is in the period of exclusion of another study.
研究组 & 干预措施
Compression device
Experimental
干预措施: Compression device (Device)
结局指标
主要结局
Recurrence of keloid scar
时间窗: 12 month
Recurrence will be assessed during each visit by surgeon
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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