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Anti-infective
Povidone-Iodine for Surgical Site Infections
Phase 3
Recruiting
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between date of surgery and 30 days post-operatively
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will test if using a combination of a specific type of wound irrigation and peritoneal lavage during emergency surgeries is better than using normal saline in patients between 18 and 80 years old
Who is the study for?
This trial is for men and women aged 18-80 who are undergoing emergency abdominal surgery (laparotomies) with a moderate to high risk of infection. Participants must have wounds classified as CDC class 2 or 3, indicating some degree of contamination.
What is being tested?
The study is testing if washing out the surgical area with diluted povidone-iodine solution is better at preventing infections than using normal saline. It's a large study involving multiple centers where patients are randomly chosen to receive one treatment or the other.
What are the potential side effects?
Povidone-Iodine may cause skin irritation or allergic reactions in some people. Normal saline is generally well-tolerated but can sometimes lead to mild discomfort at the site of irrigation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between date of surgery and 30 days post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between date of surgery and 30 days post-operatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Surgical Site Infection
Secondary study objectives
Ileus
Readmission
Return to the Operating Room
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound IrrigationExperimental Treatment1 Intervention
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.
Group II: Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound IrrigationActive Control1 Intervention
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Povidone-Iodine
2017
Completed Phase 4
~8970
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
265,575 Total Patients Enrolled