Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

Cook Group Incorporated0 个研究点开始时间: 2016年1月12日最近更新: 2017年2月13日

适应症

试验速览

阶段: 不适用
状态: 撤回
发起方: Cook Group Incorporated
主要终点: Number of patients that develop a surgical site infection

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

This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

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: 21 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

排除标准

•Less than 21 years old
•Unwilling or unable to sign and date the informed consent
•Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
•Unable or unwilling to comply with follow-up schedule
•Simultaneously participating in another investigational drug or device study.
•Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

结局指标

主要结局

Number of patients that develop a surgical site infection

时间窗: 6 months

Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.

次要结局

Frequency of procedural and post-operative adverse events(24 months)
Number of hernia recurrences(24 months)

研究者

发起方

Cook Group Incorporated

申办方类型

Industry

责任方

Sponsor

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