A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound With Gentamicin- Saline Solution Versus Saline Solution for Prevention of Surgical Site Infection.
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution.
The present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional SSI after open appendectomy for acute appendicitis. We postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional SSI by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the McBurney's incision.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. Acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix.
排除标准
- •Patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.
研究组 & 干预措施
Saline-gentamicin irrigation
layer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution
干预措施: saline-gentamicin irrigation (Procedure)
Saline irrigation
layer-by-layer irrigation of the appendectomy wound will be performed using Saline solution
干预措施: saline irrigation (Procedure)
No irrigation
ayer-by-layer irrigation of the appendectomy wound will not be performed
结局指标
主要结局
Incidence of surgical site infection
时间窗: 6 weeks after surgery
SSI was defined according to the standard criteria devised by the center for disease and control (CDC). Purulent drainage from the wound, cellulitis requiring antibiotics, or the opening of a closed wound were considered criteria of Incisional SSI
次要结局
未报告次要终点
研究者
Sameh Emile
Associate professor of surgery
Mansoura University