NCT01880021已完成不适用
Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Fibrosis level of explanted mesh
研究概览
简要总结
The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fibrosis level of explanted mesh
时间窗: Within 2 weeks
Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.
次要结局
- Number of subjects with corticosteroid/immunosuppression therapy(Within 2 weeks)
- Tensile strength of explanted mesh(Within 2 weeks)
- Number of subjects with history of chemotherapy(Within 2 weeks)
- Collagen protein levels of explanted mesh.(Within 2 weeks)
- Number of subjects with history of radiation to abdomen/pelvis(Within 2 weeks)
- Number of subjects with history of tobacco use(Within 2 weeks)
研究者
研究点 (1)
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