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

Last updated: October 15, 2024
Sponsor: Loma Linda University
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Povidone-Iodine

Normal Saline

Clinical Study ID

NCT06363877
5220078
  • Ages 18-80
  • All Genders

Study 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

Inclusion Criteria:

  • 18 to 80 years of age

  • undergoing an exploratory laparotomy for Centers for Disease Control class II andIII wounds

Exclusion

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

Total Participants: 1100
Treatment Group(s): 2
Primary Treatment: Povidone-Iodine
Phase: 3
Study Start date:
June 03, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Loma Linda University Health

    Loma Linda, California 92354
    United States

    Active - Recruiting

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