The Effect of Intraoperative Peritoneal Lavage With Super-Oxidized Solution on Surgical Site Infections and Mortality in Patients With Secondary Peritonitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Composite endpoint of surgical site infection and mortality
研究概览
简要总结
Secondary peritonitis is a frequent abdominal emergency that is still associated with a high morbidity and mortality rate due to surgical site infections (SSI) and sepsis. Early surgical source control is crucial to avoid sepsis and worse outcomes. The current randomized controlled trial aims to investigate the effect of peritoneal lavage with super-oxidized solution (SOS) on SSI and mortality in patients undergoing emergency abdominal surgery for secondary peritonitis. The investigators hypothesize that peritoneal lavage with SOS reduces the incidence of SSI and mortality in this patient population.
详细描述
Secondary peritonitis is a frequent abdominal emergency that is associated with significant mortality and morbidity, especially surgical site infections (SSI). If not treated promptly and efficiently, secondary peritonitis may progress from a contained abdominal infection to systemic disease, i.e., sepsis and eventually septic shock. Early surgical source control is crucial to avoid sepsis and worse outcomes. Super-oxidized solution (SOS) has been shown to have a strong antimicrobial activity while being safe for medical use in humans.
This randomized controlled trial (RCT) will investigate the effect of peritoneal lavage with SOS vs. the current standard solution (Ringer) on SSI and mortality in patients undergoing emergency abdominal surgery (EAS) for secondary peritonitis. The hypothesis of this study is that peritoneal lavage with SOS during EAS will reduce the incidence of SSI and mortality.
Patients scheduled for open EAS with secondary peritonitis due to suspected hollow-viscus perforation, anastomotic insufficiency, or abdominal abscess, including patients with the named abdominal emergencies as a complication after elective surgery, will be assessed for eligibility. All patients included will be treated according to the current standard of care for secondary peritonitis. This includes the insertion of intravenous lines, start of antibiotic therapy, infusion of crystalloid solutions, monitoring of vital signs, and EAS.
Randomization will take place during EAS after the surgical procedure including regular peritoneal lavage have been performed. If a hollow-viscus perforation, anastomotic insufficiency, or an abdominal abscess is encountered intraoperatively, patients will be randomized and undergo additional peritoneal lavage with either SOS (SOS group) or Ringer's solution (control group).
In the SOS group, the abdominal cavity will be irrigated with 2 liters of SOS (Micodacyn60®), followed by aspiration of the product and abdominal closure. In the control group, the abdominal cavity will be irrigated with two liters of Ringer's solution, followed by aspiration of the solution and abdominal closure. The only difference in treatment between the two groups will be the additional peritoneal lavage with SOS or Ringer's solution at the end of the procedure. After surgery, there will be no difference in the management of the SOS and control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary peritonitis due to suspected hollow viscus perforation, anastomotic insufficiency, and/or abdominal abscess (including patients with the named abdominal emergencies as a complication after elective surgery)
- •Scheduled emergency abdominal surgery by laparotomy with peritoneal lavage
- •Age over 18 years
- •Written informed consent
- •Exclusion Criteria
- •Pregnancy (will be ruled out using beta-hCG testing in women of childbearing potential)
- •Patients with primary or tertiary peritonitis
排除标准
- 未提供
结局指标
主要结局
Composite endpoint of surgical site infection and mortality
时间窗: 30 days
The primary composite endpoint will be the proportion of patients who have a surgical site infection or die within 30 days postoperatively.
次要结局
- White blood count(14 days)
- Reintervention for postoperative complications(30 days)
- Total hospital length of stay(Hospital stay, expected to be up to two weeks)
- Postoperative intestinal fistula(30 days)
- 30-day mortality(30 days)
- Sepsis(7 days)
- In-hospital mortality(Hospital stay, expected to be up to two weeks)
- Surgical site infection(30 days)
- Intensive care unit length of stay(Intensive care unit stay, expected to be up to one week)
- Time to primary outcome(30 days)
- Septic shock(7 days)
- Organ dysfunction based on SOFA score(14 days)
- C-reactive protein(14 days)
- Body temperature(14 days)
- Postoperative fascial dehiscence(30 days)
- Time to first postoperative bowel movement(30 days)
- Organ dysfunction based on qSOFA score(14 days)