NCT01706848已完成不适用
A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound
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
- 60
- 试验地点
- 9
- 主要终点
- Safety
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 improve wound healing and the resulting scar consequences following suturing of a wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 a surgical 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
研究组 & 干预措施
Celotres
Active Comparator
Scar halves randomized to treatment with device, opposite side treated per standard of care.
干预措施: Celotres (Other)
Standard surgical wound closure
Active Comparator
Scar halves randomized to treatment with device, opposite side treated per standard of care.
干预措施: Surgical Closure by Standard of Care (Other)
结局指标
主要结局
Safety
时间窗: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Safety as defined by the incidence of device related adverse events.
次要结局
- Effectiveness(Assessed at Months 1, 3, 6, 9 and 12)
- Device Performance Evaluation(Assessed at Day 1)
研究者
研究点 (9)
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