Recruiting
Phase 3

Povidone-Iodine & Saline

Sponsor:

Loma Linda University

Code:

NCT06363877

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Povidone-Iodine

Normal Saline

Study Details

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

Study ID

NCT06363877

Start date

Jun 3, 2024

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Martin G Rosenthal, MD

909-558-4000mrosenthal@ll.edu

Mohamed H El-Farra, MD

melfarra@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Martin G Rosenthal, MD

mrosenthal@llu.edu

Principal Investigator:

Martin Rosenthal, MD

More Information

Sponsor

Loma Linda University

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2025-11-19.