Status and phase
Conditions
Treatments
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:
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
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,100 participants in 2 patient groups
Loading...
Central trial contact
Martin G Rosenthal, MD; Mohamed H El-Farra, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal