Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Recruiting
Phase 3
Interventional Study
Surgical Site Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,100 (estimated)
- Sponsor
- Loma Linda University · Other
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About This Trial
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…
Trial Locations
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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
* Pati…
Contacts