Comparing diluted povidone-iodine and saline to reduce surgical site infections
Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
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 |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT06363877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 undergoing exploratory laparotomy for CDC class II and III wounds.
Not a fit: Patients who are pregnant, have iodine allergies, or preoperative infections will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Loma Linda, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.