NCT02401334已完成不适用
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Incidence of Surgical Site Infection
研究概览
简要总结
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
排除标准
- •Body Mass Index (BMI) <
- •Body weight < 45 kg
- •Glycosylated Hemoglobin (Hgb A1c) > 10%
- •Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL
- •Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
- •Known allergies to study device components
- •Other relevant exclusion criteria apply
研究组 & 干预措施
Hernia Repair
Experimental
Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.
干预措施: Cook® Antimicrobial Hernia Repair Device (Device)
结局指标
主要结局
Incidence of Surgical Site Infection
时间窗: 6 months
次要结局
- Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).(12 months)
研究者
研究点 (8)
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