Comparing diluted povidone-iodine and saline to reduce surgical site infections
Official title: Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Run by Loma Linda University · NCT06363877 · Data updated 2026-11-12
This study is testing whether using diluted povidone-iodine instead of saline during surgery can help prevent infections in patients having emergency abdominal surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | October 2026 |
| Study ends | November 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT06363877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 undergoing exploratory laparotomy for CDC class II and III wounds.
✕Probably not a fit
Patients who are pregnant, have iodine allergies, or preoperative infections will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of diluted aqueous povidone-iodine compared to normal saline for intraoperative wound irrigation and peritoneal lavage in patients undergoing emergency laparotomies. The study will enroll 1100 patients aged 18 to 80 with CDC class 2 and 3 wounds, assessing both the reduction of surgical site infections and the safety of the povidone-iodine solution. Participants will be followed for 18 months, with evaluations up to 30 days post-surgery to monitor outcomes and any adverse events.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections in patients undergoing emergency laparotomies.
How similar studies have gone: Previous studies have shown promising results with povidone-iodine in reducing infections, but this specific approach is being evaluated for the first time in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 80 years of age * undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds Exclusion Criteria: * 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
Where it's running
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Loma Linda University Health
Loma Linda, California, United States Recruiting
Study contacts
- Study coordinator: Martin G Rosenthal, MD
- Email: mrosenthal@ll.edu
- Phone: 909-558-4000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.