跳至主要内容
临床试验/NCT00484887
NCT00484887终止不适用

Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
272
试验地点
1

研究概览

简要总结

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

详细描述

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. The objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 (persons 18 and older)
  • Previous placement of hernia mesh material
  • Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure

排除标准

  • No retained mesh prosthetic
  • Non surgical candidate

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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