NCT00892333已完成不适用
Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 8
- 主要终点
- Hernia recurrence
研究概览
简要总结
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All three of the following criteria must be present for enrollment into the study:
- •Large abdominal hernia
- •Inability to close the fascia primarily
- •Contra-indication for the use of synthetic mesh
- •Age > 18 years
排除标准
- •Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
- •Inability to close the skin over the SurgiMend 3.0
结局指标
主要结局
Hernia recurrence
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (8)
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