Reduction of Postoperative Wound Infections by Antiseptica?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- surgical site infection
研究概览
简要总结
Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.
详细描述
Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •planned laparotomy for visceral surgery
排除标准
- •Age under 18 years
- •allergy against polihexanid
- •laparoscopic surgery
- •emergency surgery
- •lack of understanding of the trial
研究组 & 干预措施
Subcutaneous irrigation with 0.04% polyhexanide solution
Intervention: after closure of abdominal fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml antiseptic solution (0.04% polyhexanide) will be done once for ten minutes.
No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.
干预措施: Polihexanide; Serasept (Drug)
Subcutaneous irrigation with NaCl (saline)
Intervention: after closure of fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml NaCl (saline) will be done once for one minute.
No subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.
干预措施: NaCl; saline (Drug)
结局指标
主要结局
surgical site infection
时间窗: 30 days postoperatively
Surgical site infection according to CDC definition.
次要结局
未报告次要终点
研究者
Johannes Lauscher
Principal investigator, MD, PhD, Staff surgeon, Department of General, Visceral and Vascular Surgery
Charite University, Berlin, Germany