Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

NCT06363877 Phase 3 RECRUITING

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.

Details

Lead sponsor	Loma Linda University
Phase	Phase 3
Status	RECRUITING
Enrolment	1100
Start date	2024-06-03
Completion	2026-11

Conditions

• Surgical Site Infection

Interventions

• Povidone-Iodine
• Normal Saline

Primary outcomes

• 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

Countries

United States