Clinical trial NCT06363877: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Official title: Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Surgical Site Infection
Keywords: Intraoperative Wound Irrigation
Intraoperative Peritoneal Lavage
Povidone-Iodine
Normal Saline
Exploratory Laparotomy
Clean Contaminated Wounds
Contaminated Wounds
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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: 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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)
Secondary outcomes:
measure: Readmission
timeFrame: Between date of surgery and 30 days post-operatively
measure: Return to the Operating Room
timeFrame: Between date of surgery and 30 days post-operatively
measure: Ileus
timeFrame: Between date of surgery and 30 days post-operatively
measure: Small Bowel Obstruction
timeFrame: Between date of surgery and 30 days post-operatively
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
References: