Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Surgical Site Infection
研究概览
简要总结
This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds.
详细描述
The main objective is stated in the Brief Summary. The secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for CDC class 2 and 3 wounds.
The main questions this study aims to answer are:
- Does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections?
- Is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline?
- Are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on CDC class 2 and 3 wounds compared to normal saline?
Subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. Randomization of patients will occur prior to going to beginning the emergency laparotomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
排除标准
- •Pregnancy
- •Preoperative abdominal wall skin/soft tissue infection
- •Iodine allergy
- •Patients unlikely to survive beyond 30 days
- •Patients with mesh placement or placement of a foreign body except for drains
研究组 & 干预措施
Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.
干预措施: Povidone-Iodine (Drug)
Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Surgical Site Infection
时间窗: Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)
Subjects in each study arm will be assessed for presence of surgical site infection using a composite measurement based on the CDC/NHSN Guidelines for Surgical Site Infection (SSI) Event (January 2024). The presence of one or more of the following will constitute a surgical site infection: 1. purulent drainage from the superficial incision, deep incision or the drain in an organ/space 2. organism(s) identified from an aseptically-obtained specimen from the superficial incision, subcutaneous tissue, deep soft tissues, or fluid or tissue in the organ space by a culture or nonculture based microbiologic testing method 3. an incision that is deliberately opened by a provider AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat 4. an abscess or other evidence of infection involving the deep incision or organ/space detected on gross anatomical exam, histopathologic exam, or imaging test
次要结局
- Readmission(Between date of surgery and 30 days post-operatively)
- Return to the Operating Room(Between date of surgery and 30 days post-operatively)
- Ileus(Between date of surgery and 30 days post-operatively)
- Small Bowel Obstruction(Between date of surgery and 30 days post-operatively)