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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT06363877
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 3, 2024
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92354
Martin G Rosenthal, MD
[email protected]
Martin Rosenthal, MD (PRINCIPAL_INVESTIGATOR)
Mohamed H El-Farra, MD (SUB_INVESTIGATOR)

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Loma Linda University Health· Loma Linda, CA

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