A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Flap failure rate compared to published rate for conventional suture anastomoses
研究概览
简要总结
This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.
详细描述
Within Scott & White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.
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
- •either gender
- •any ethnicity
- •patient requiring free tissue transfer for complex wound coverage or reconstruction
- •patient having arterial anastomotic diameter of at least 2 mm
- •patient capable of giving informed consent
排除标准
- •less than 18 years of age
- •allergy to nitinol or any of its components (nickel or titanium)
- •pregnancy
- •known coagulopathy
结局指标
主要结局
Flap failure rate compared to published rate for conventional suture anastomoses
时间窗: will be measured 3 months postoperative (+/- 2 weeks)
次要结局
- Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.(data collected at 3 months postoperative (+/- 2 weeks))