A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 7
- 主要终点
- The incidence of device related adverse events
研究概览
简要总结
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients electing to undergo keloid excision procedure
- •Patients able and willing to give written informed consent
排除标准
- •Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.
结局指标
主要结局
The incidence of device related adverse events
时间窗: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Device safety is defined as the incidence of device related adverse events.
Recurrence of keloid post scar excision
时间窗: Assessed at 1, 3, 6, 9 and 12 months
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume \>0.3cc
次要结局
- Patient and Observer Scar Assessment Scale (POSAS)(Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12)
- Subject Dermatology Life Quality Index (DLQI)(Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12)
- Device Performance Evaluation(Assessed at Day 1)