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

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.

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.

Eligibility Criteria

Interventions