Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- port site infection (PSI)
研究概览
简要总结
Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
详细描述
In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75
- •candidate for laparoscopic surgical intervention during the period of the study were included.
排除标准
- •Patient has immunodeficiency disorder.
- •Patient receiving anti-cancer / immunosuppressive therapy.
- •Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
研究组 & 干预措施
Coated Polyglactin 910 with Triclosan
Coated Polyglactin 910 with Triclosan
干预措施: Coated Vicryl plus (Drug)
Coated Polyglactin 910 without Triclosan
Coated Polyglactin 910 without Triclosan
干预措施: Coated vicryl (Drug)
结局指标
主要结局
port site infection (PSI)
时间窗: 30 days
the incidence of port site infection (PSI)
次要结局
- hospital stay(30 days)
研究者
Emad R Issak
Doctor
Ain Shams University