RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-03
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06363877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 to 80 years of age
  2. * undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
  1. * Pregnancy
  2. * Preoperative abdominal wall skin/soft tissue infection
  3. * Iodine allergy
  4. * Patients unlikely to survive beyond 30 days
  5. * Patients with mesh placement or placement of a foreign body except for drains

Contacts and Locations

Study Contact

Martin G Rosenthal, MD
CONTACT
909-558-4000
mrosenthal@ll.edu
Mohamed H El-Farra, MD
CONTACT
melfarra@llu.edu

Study Locations (Sites)

Loma Linda University Health
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Intraoperative Wound Irrigation
  • Intraoperative Peritoneal Lavage
  • Povidone-Iodine
  • Normal Saline
  • Exploratory Laparotomy
  • Clean Contaminated Wounds
  • Contaminated Wounds

Additional Relevant MeSH Terms

  • Surgical Site Infection