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

NCT06363877 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 5220078
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Intraoperative Wound Irrigation; Intraoperative Peritoneal Lavage; Povidone-Iodine; Normal Saline; Exploratory Laparotomy; Clean Contaminated Wounds; Contaminated Wounds

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  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

  Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)

Secondary Outcomes (4)

• Readmission

  Between date of surgery and 30 days post-operatively

• Return to the Operating Room

  Between date of surgery and 30 days post-operatively

• Ileus

  Between date of surgery and 30 days post-operatively

• Small Bowel Obstruction

  Between date of surgery and 30 days post-operatively

Study Arms (2)

Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

EXPERIMENTAL

Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.

Drug: Povidone-Iodine

Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

ACTIVE COMPARATOR

Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.

Drug: Normal Saline

Interventions

Povidone-Iodine DRUG

Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of dilute aqueous povidone-iodine solution allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the povidone-iodine solution then wash-out with 2L of normal saline followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL povidone-iodine solution, suctioned, then washed-out with 500 mL normal saline.

Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

Normal Saline DRUG

Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of normal saline allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the solution, wash-out with 2L of normal saline, followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL normal saline solution, suctioned, then washed-out with 500 mL normal saline.

Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Martin G Rosenthal, MD

CONTACT

909-558-4000; mrosenthal@ll.edu

Mohamed H El-Farra, MD

CONTACT

melfarra@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)