NCT06363877 · Loma Linda University
Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
What this study is about
This is a conducted at multiple hospitals randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Povidone-Iodine
Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of dilute aqueous povidone-iodine solution allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the povidone-iodine solution then wash-out with 2L of normal saline followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL povidone-iodine solution, suctioned, then washed-out with 500 mL normal saline.
DRUG
Normal Saline
Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of normal saline allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the solution, wash-out with 2L of normal saline, followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL normal saline solution, suctioned, then washed-out with 500 mL normal saline.
Primary outcome measures
Surgical Site Infection
Time frame: Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)
Subjects in each study arm will be assessed for presence of surgical site infection using a composite measurement based on the CDC/NHSN Guidelines for Surgical Site Infection (SSI) Event (January 2024). The presence of one or more of the following will constitute a surgical site infection: 1. purulent drainage from the superficial incision, deep incision or the drain in an organ/space 2. organism(s) identified from an aseptically-obtained specimen from the superficial incision, subcutaneous tissue, deep soft tissues, or fluid or tissue in the organ space by a culture or nonculture based microbiologic testing method 3. an incision that is deliberately opened by a provider AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat 4. an abscess or other evidence of infection involving the deep incision or organ/space detected on gross anatomical exam, histopathologic exam, or imaging test
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 to 80 years of age
- undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
Exclusion criteria
- 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
Where
- Loma Linda, California
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations