Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
- Conditions
- Surgical Site Infection
- Interventions
- Drug: Normal Saline
- Registration Number
- NCT06363877
- Lead Sponsor
- Loma Linda University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- 18 to 80 years of age
- undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation Normal Saline Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution. Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation Povidone-Iodine Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.
- Primary Outcome Measures
Name Time Method Surgical Site Infection 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
- Secondary Outcome Measures
Name Time Method Readmission Between date of surgery and 30 days post-operatively Subjects in each study arm will be assessed for the number of times the subject has been readmitted into the hospital for any cause. This will be tracked by chart review and follow-up until 30 days after the initial operation.
Return to the Operating Room Between date of surgery and 30 days post-operatively Subjects in each study arm will be assessed for the number of times the subject returns to the operating room for any cause. This will be tracked throughout the hospital stay and post-discharge by chart review and follow-up until 30 days after the initial operation.
Ileus Between date of surgery and 30 days post-operatively Subjects in each study arm will be assessed for the development of an ileus. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with no transition point identified.
Small Bowel Obstruction Between date of surgery and 30 days post-operatively Subjects in each study arm will be assessed for the development of a small bowel obstruction. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with a transition point identified. Additional testing including an upper gastrointestinal series (e.g. small bowel follow through) can be used in a case-by-case if medically necessary for diagnosis.
Trial Locations
- Locations (1)
Loma Linda University Health
🇺🇸Loma Linda, California, United States