NCT00531739已完成4 期
Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery
Cytori Therapeutics2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assess the efficacy of SurgiWrapTM in the prevention/reduction of Grade 2 or higher soft tissue attachments under the abdominal incision made during colorectal surgery
研究概览
简要总结
The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the incidence of Grade 2 or higher soft tissue attachments under the incision made during abdominal surgery, (2) reduces post-operative bowel obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient is 18 years of age or older of either gender
- •Patient has primary diagnosis requiring a two-stage colectomy or procto-colectomy
- •Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before randomization.
- •Patient must be able and willing to follow study procedures and instructions.
排除标准
- •Patient is participating in another clinical study which may influence adhesion formation.
- •Patient has had barriers, solutions, or anti-adhesive therapy, other than SurgiWrapTM, as planned at randomization, placed in the abdomen at the time of the initial surgery
- •Patient who, at the initial surgery, had administration of irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or dextran 70
- •Patient has one or more medical condition(s), including severe renal, hepatic, hematologic, neurologic, or immune disease that, in the opinion of the Investigator, would make the patient an inappropriate candidate for this study.
- •Patient is taking chronic (i.e., > 2 weeks) therapeutic doses of medications known to affect healing such as nonsteroidal anti-inflammatory drugs. Prophylactic aspirin (less than or equal to 325 mg once daily) for cardiovascular indications will be permitted in patients.
- •Patient has an infection in the intra-abdominal or pelvic area.
结局指标
主要结局
Assess the efficacy of SurgiWrapTM in the prevention/reduction of Grade 2 or higher soft tissue attachments under the abdominal incision made during colorectal surgery
时间窗: 6 months
次要结局
- Clinical and radiographic evidence of bowel obstruction(5 to 30 days)
- The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery(6 months)
研究者
研究点 (2)
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