Povidone-Iodine for Surgical Site Infection
(POTENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if applying a special solution inside the noses of patients with severe leg, ankle, or foot fractures can reduce their risk of infections after surgery. These patients need quick operations and are at high risk for infections. The solution helps by killing bacteria that could cause these infections. This solution is widely used among surgeons for its effectiveness in reducing infections after surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Povidone-Iodine safe for use in humans?
Povidone-Iodine (also known as Betadine or PVP-I) has been used safely in various medical settings, including heart surgery and cataract surgery, for skin and wound disinfection. While minor skin issues can occur, serious infections are rare and often related to other factors. Long-term safety data is limited, but it is generally considered safe for short-term use.12345
How is the drug Povidone-Iodine Topical Ointment unique for preventing surgical site infections?
Povidone-Iodine Topical Ointment is unique because it has a broad antibacterial spectrum and is less likely to cause skin irritation due to its low free iodine concentration. It is also cost-effective and has not shown bacterial resistance, making it a reliable option for surgical site infection prevention.25678
What data supports the effectiveness of the treatment Povidone-Iodine Topical Ointment for preventing surgical site infections?
Who Is on the Research Team?
Loreen Herwaldt, MD
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
Adults over 18 facing surgery for severe leg, ankle, or foot fractures may join this trial. It's not for those allergic to iodine, pregnant women, patients with active infections at the fracture site, prisoners, individuals unable to follow up post-surgery (like homeless or intellectually challenged without support), or those who can't consent due to mental impairment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Intranasal povidone-iodine (PDI Profend) is applied to the patients' noses 60 minutes before surgery and approximately 12 hours after the first application.
Follow-up
Participants are monitored for surgical site infections and other complications for 6 months after the initial surgical procedure.
What Are the Treatments Tested in This Trial?
Interventions
- Povidone-Iodine Topical Ointment
Povidone-Iodine Topical Ointment is already approved in United States, European Union, China for the following indications:
- Preoperative skin preparation
- Wound care
- Surgical site infection prevention
- Preoperative skin preparation
- Wound care
- Surgical site infection prevention
- Preoperative skin preparation
- Wound care
- Surgical site infection prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loreen Herwaldt
Lead Sponsor
Emory University
Collaborator
PDI Healthcare
Collaborator
University of Texas
Collaborator
University of Utah
Collaborator
Centers for Disease Control and Prevention
Collaborator
Washington University School of Medicine
Collaborator
Indiana University
Collaborator