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

November 17, 2025 updated by: Loma Linda University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective is stated in the Brief Summary. The secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for CDC class 2 and 3 wounds.

The main questions this study aims to answer are:

  • Does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections?
  • Is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline?
  • Are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on CDC class 2 and 3 wounds compared to normal saline?

Subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. Randomization of patients will occur prior to going to beginning the emergency laparotomy.

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health
        • Contact:
        • Principal Investigator:
          • Martin Rosenthal, MD
        • Sub-Investigator:
          • Mohamed H El-Farra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.
Drug: Povidone-Iodine

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.
Active Comparator: Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.
Drug: Normal Saline

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: 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
Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: Between date of surgery and 30 days post-operatively
Subjects in each study arm will be assessed for the number of times the subject has been readmitted into the hospital for any cause. This will be tracked by chart review and follow-up until 30 days after the initial operation.
Between date of surgery and 30 days post-operatively
Return to the Operating Room
Time Frame: Between date of surgery and 30 days post-operatively
Subjects in each study arm will be assessed for the number of times the subject returns to the operating room for any cause. This will be tracked throughout the hospital stay and post-discharge by chart review and follow-up until 30 days after the initial operation.
Between date of surgery and 30 days post-operatively
Ileus
Time Frame: Between date of surgery and 30 days post-operatively
Subjects in each study arm will be assessed for the development of an ileus. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with no transition point identified.
Between date of surgery and 30 days post-operatively
Small Bowel Obstruction
Time Frame: Between date of surgery and 30 days post-operatively
Subjects in each study arm will be assessed for the development of a small bowel obstruction. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with a transition point identified. Additional testing including an upper gastrointestinal series (e.g. small bowel follow through) can be used in a case-by-case if medically necessary for diagnosis.
Between date of surgery and 30 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5220078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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