NCT03482999已完成不适用
Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- reduce the post-operative duration of stay
研究概览
简要总结
To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.
详细描述
A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing a procedure for decubitus repair
- •be 22 years of age or older
排除标准
- •expected flap size less than 5 sqcm
结局指标
主要结局
reduce the post-operative duration of stay
时间窗: 30 days
duration
reduce the surgical revision rate
时间窗: 30 days
rate
次要结局
- duration of wound drainage(30 days)
- percent of patients requiring a revision(30 days)
研究者
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