NCT01181206已完成不适用
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2010年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- Surgical site infections
研究概览
简要总结
BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the numbers of surgical site infections in two different techniques of covering the abdominal wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™ Steri-Drape™ Wound Edge Protector.
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
- Double (Participant, 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
- •Ability to sign the informed consent
- •Patients older than 18 years
- •Abdominal operations with longitudinal / cross section with clean wounds, clean-contaminated wounds or contaminated wounds (cdc-definitions of surgical wound infections)
排除标准
- •Pregnant or lactating women
- •Revision Operations
- •Operations with dirty or infected wounds (CDC definition of surgical wound infections)
- •Laparoscopic operations
- •Small operations without longitudinal- / cross-section e.g. appendectomy
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs (Procedure)
Arm 2
Active Comparator
干预措施: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs (Procedure)
结局指标
主要结局
Surgical site infections
时间窗: 3 years
次要结局
- Body-Temperature during Operation(3 years)
研究者
研究点 (2)
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