NCT00617357已完成不适用
A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeCell
- 入组人数
- 83
- 试验地点
- 18
- 主要终点
- Incidence of Wound Events
研究概览
简要总结
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •is an adult ≥18 years old.
- •has need of open abdominal incisional repair of a contaminated or infected site
- •has an estimated hernia size of >9cm2 by physical exam
排除标准
- •has a nidus of chronic colonization
- •has a systemic infection at the time of repair.
- •has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
- •requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
- •is bedridden or otherwise non-ambulatory.
- •is ASA Class 4 or
- •has a BMI >
- •has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.
结局指标
主要结局
Incidence of Wound Events
时间窗: Postoperatively up to 24 months
Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
次要结局
- Activities Assessment Scale (AAS)(24 Months)
研究者
研究点 (18)
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