Comparing Diluted Aqueous Povidone-Iodine to Saline for Reducing Surgical Site Infections During Emergency Laparotomies in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating whether using a diluted aqueous povidone-iodine solution combined with intraoperative wound irrigation and peritoneal lavage can reduce surgical site infections compared to normal saline in adults aged 18 to 80 undergoing emergency laparotomies. This phase 3, multicenter, randomized controlled trial includes patients with Centers for Disease Control CDC class 2 and 3 wounds. The study also aims to assess the safety and any adverse effects of povidone-iodine compared to saline in this surgical setting. Participants are randomly assigned to one of two groups. One group receives combined intraoperative peritoneal lavage and wound irrigation using diluted aqueous povidone-iodine, where the peritoneum is washed with 1 liter of the solution and the wound irrigated with 500 mL, followed by saline washes. The other group receives the same procedures but with normal saline only. The irrigation and lavage are performed during surgery with specific volumes and timing for each solution. During the study, participants are monitored for up to 30 days after surgery for surgical site infections, readmissions, return to the operating room, ileus, and small bowel obstruction. The total follow-up lasts up to 18 months. Researchers track these outcomes through postoperative visits and assessments to determine the impact and safety of the irrigation methods.

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