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

Surgical Site Infection Clinical Trial

Official title:

Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363877
• Other study ID #: 5220078
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: Loma Linda University
• Contact: Martin G Rosenthal, MD
• Phone: 909-558-4000
• Email: mrosenthal[@]ll.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: November 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	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: purulent drainage from the superficial incision, deep incision or the drain in an organ/space; 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; 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; an abscess or other evidence of infection involving the deep incision or organ/space detected on gross anatomical exam, histopathologic exam, or imaging test	Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)
Secondary	Readmission	Subjects in each study arm will be assessed for the number of times the subject has been readmitted into the hospital for any cause. This will be tracked by chart review and follow-up until 30 days after the initial operation.	Between date of surgery and 30 days post-operatively
Secondary	Return to the Operating Room	Subjects in each study arm will be assessed for the number of times the subject returns to the operating room for any cause. This will be tracked throughout the hospital stay and post-discharge by chart review and follow-up until 30 days after the initial operation.	Between date of surgery and 30 days post-operatively
Secondary	Ileus	Subjects in each study arm will be assessed for the development of an ileus. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with no transition point identified.	Between date of surgery and 30 days post-operatively
Secondary	Small Bowel Obstruction	Subjects in each study arm will be assessed for the development of a small bowel obstruction. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with a transition point identified. Additional testing including an upper gastrointestinal series (e.g. small bowel follow through) can be used in a case-by-case if medically necessary for diagnosis.	Between date of surgery and 30 days post-operatively