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

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.

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.

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