RecruitingPhase 3NCT06363877

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

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

Sponsor

Loma Linda University

Enrollment

1,100 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Surgical Site Infection

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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

Exclusion Criteria5

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

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Interventions

DRUGPovidone-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.

DRUGNormal 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.