NCT03481140已完成不适用
Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- number of post-operative clinical interventions related to wound fluid management at the donor site
研究概览
简要总结
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •be 18 years of age or older
- •be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
- •have a body mass index (BMI) < 28
- •have received a DIEP flap breast reconstruction procedure
排除标准
- •current smoker
- •have a body mass index (BMI) > 28
- •taking active SSRI medication prescriptions
结局指标
主要结局
number of post-operative clinical interventions related to wound fluid management at the donor site
时间窗: 6 weeks post-operatively
number of interventions
次要结局
- total wound drainage(6 weeks post-operatively)
- cumulative drain volume(6 weeks post-operatively)
- days to drain removal(6 weeks post-operatively)
- aspiration volume(6 weeks post-operatively)
- cumulative days of invasive treatment(6 weeks post-operatively)
研究者
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