NCT00930787终止4 期
A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
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
- 否
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
研究点 (26)
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