NCT01002287终止不适用
An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
研究概览
简要总结
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
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
- Single (Participant)
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
- •Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
排除标准
- 未提供
研究组 & 干预措施
SprayShield Adhesion Barrier
Experimental
SprayShield Adhesion Barrier
干预措施: SprayShield Adhesion Barrier System (Device)
Control
Sham Comparator
Good Surgical Technique Alone
干预措施: Good Surgical Technique Alone (Procedure)
结局指标
主要结局
The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
时间窗: 10-12 Weeks post Initial Surgery for J-Pouch
次要结局
- Severity of Adhesions(Average 10-12 weeks post surgery)
- Adhesion Involvement Along the Midline Incision (Percentage)(average 10-12 weeks post surgery)
- Mobilization Time(average 10-12 weeks post surgery)
研究者
研究点 (1)
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