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

Cohera Medical, Inc.0 个研究点目标入组 58 人开始时间: 2015年4月21日最近更新: 2018年3月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cohera Medical, Inc.
入组人数: 58
主要终点: number of post-operative clinical interventions related to wound fluid management at the donor site

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

发起方

Cohera Medical, Inc.

申办方类型

Industry

责任方

Sponsor

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