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Recruiting Phase 3 NCT06363877

Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

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Trial Parameters

Condition Surgical Site Infection
Sponsor Loma Linda University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-06-03
Completion 2026-10
Interventions
Povidone-IodineNormal Saline

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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.

Eligibility 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

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