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

Loma Linda University (LLU)

Status and phase: Begins enrollment this month; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Povidone-Iodine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06363877

5220078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,100 participants in 2 patient groups

Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

Experimental group

Description:

Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.

Treatment:

Drug: Povidone-Iodine

Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation

Active Comparator group

Description:

Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.

Treatment:

Drug: Normal Saline