Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of incisional surgical-site infection
研究概览
简要总结
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture
Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture
Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture
Incisional surgical.site infection and evisceration will be recorded.
详细描述
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J&J), caliber 1, 48mm-cylindric needle.
Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.
Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.
Incisional surgical.site infection and evisceration will be recorded.
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)
盲法说明
The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned.
The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.
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
- •Contaminated and Dirty surgery
- •Emergency surgery performed by midline laparotomic approach
- •The following diagnosis will be included:
- •Anastomotic leak of previous digestive surgery (colon, small bowel or gastric surgery)
- •Colonic or bowel perforations
- •Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy
- •Perforation of gastric or duodenal ulcer
- •Intestinal ischemia requiring bowel resection
排除标准
- •Emergency surgery undergoing laparoscopic approach
- •Appendicitis operated by McBurney incision
- •Intestinal isquemia without requiring bowel resection
结局指标
主要结局
Rate of incisional surgical-site infection
时间窗: 30 days postoperatively
Diagnosis of incisional surgical-site infection during the postoperative course
次要结局
- Rate of Evisceration(30 days postoperatively)
研究者
Jaime Ruiz-Tovar, MD, PhD
Professor of Surgery
Hospital General Universitario Elche