Actively Recruiting
Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Led by Loma Linda University · Updated on 2025-11-19
1100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a diluted aqueous povidone-iodine solution combined with intraoperative wound irrigation and peritoneal lavage can reduce surgical site infections compared to normal saline in adults aged 18 to 80 undergoing emergency laparotomies. This phase 3, multicenter, randomized controlled trial includes patients with Centers for Disease Control (CDC) class 2 and 3 wounds. The study also aims to assess the safety and any adverse effects of povidone-iodine compared to saline in this surgical setting. Participants are randomly assigned to one of two groups. One group receives combined intraoperative peritoneal lavage and wound irrigation using diluted aqueous povidone-iodine, where the peritoneum is washed with 1 liter of the solution and the wound irrigated with 500 mL, followed by saline washes. The other group receives the same procedures but with normal saline only. The irrigation and lavage are performed during surgery with specific volumes and timing for each solution. During the study, participants are monitored for up to 30 days after surgery for surgical site infections, readmissions, return to the operating room, ileus, and small bowel obstruction. The total follow-up lasts up to 18 months. Researchers track these outcomes through postoperative visits and assessments to determine the impact and safety of the irrigation methods.
CONDITIONS
Brief Title
Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 80 years of age
- Undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure
Participants undergo emergency laparotomy surgery during which they receive combined intraoperative peritoneal lavage and wound irrigation using either diluted aqueous povidone-iodine or normal saline solution.
1 intraoperative visit
Duration - Up to 30 days post-operatively
Participants are monitored for safety, adverse events, and surgical site infections up to 30 days after surgery.
Approximately 1 post-operative follow-up visit
Trial Site Locations
Total: 1 location
1
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
Research Team
M
Martin G Rosenthal, MD
M
Mohamed H El-Farra, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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