Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

C. R. Bard85 个研究点分布在 5 个国家目标入组 477 人2019年12月12日

适应症Open Midline Laparotomy

干预措施Phasix™ Mesh

概览

阶段: 不适用
干预措施: Phasix™ Mesh
疾病 / 适应症: Open Midline Laparotomy
发起方: C. R. Bard
入组人数: 477
试验地点: 85
主要终点: Rate of Incisional Hernia
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.

详细描述

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

注册库

clinicaltrials.gov

开始日期

2019年12月12日

结束日期

2031年12月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

C. R. Bard

责任方

Sponsor

入排标准

入选标准

•Must be ≥ 18 years of age
•Elective, open midline laparotomy ≥ 5 cm
•Willing and able to provide written informed consent
•Hernia risk equal to moderate or greater

排除标准

•Previous hernia repair
•Emergent surgery
•Creation of skin flaps is preplanned
•Preplanned 2nd surgery
•Active skin pathology
•Life expectancy less than 24 months
•Pregnant or planning to become pregnant
•Receiving a medication/medical condition that may adversely affect wound healing
•ASA Class \> IV
•Enrolled in another clinical trial

研究组 & 干预措施

Phasix™ Mesh

Prophylactic onlay placement of mesh.

干预措施: Phasix™ Mesh

Primary Suture Closure

Standard Fascial closure.

结局指标

主要结局

Rate of Incisional Hernia

时间窗: 24-Months

The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)

次要结局

Rate of Device-related Adverse Events (AEs)(60-Months)
Length of surgical procedure in minutes(Study Day 0)
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)(60-Months)
Rate of Incisional Hernia(60-Months)
Length of time for wound closure in minutes(Study Day 0)
Length of hospital stay in days(Through hospital stay, typically 3 days)