跳至主要内容
临床试验/NCT00930787
NCT00930787终止4 期

A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed

LifeCell26 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
LifeCell
入组人数
23
试验地点
26
主要终点
Incidence of Surgical Site Events (SSEs)

研究概览

简要总结

Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults of either gender
  • must have 2 or more co-morbidities

排除标准

  • local or systemic infection
  • expected survival of <24 months
  • non-ambulatory

结局指标

主要结局

Incidence of Surgical Site Events (SSEs)

时间窗: Postoperative Day 30

次要结局

未报告次要终点

研究者

发起方
LifeCell
申办方类型
Industry
责任方
Sponsor

研究点 (26)

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