Povidone-Iodine for Surgical Site Infection

(POTENT Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Loreen Herwaldt, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Loreen Herwaldt

Disqualifiers: Iodine allergy, Pregnancy, Active infection, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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.

What data supports the effectiveness of the treatment Povidone-Iodine Topical Ointment for preventing surgical site infections?

Research shows that povidone-iodine is effective in reducing bacteria on the skin before surgery, which helps prevent infections. It has been used successfully in heart surgeries and eye surgeries to lower infection rates. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

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. ^{1 3 4 7 8}

Research Team

Loreen Herwaldt, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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

I am having surgery for a high-risk fracture in my leg or foot.

I am older than 18 years.

Exclusion Criteria

Known pregnancy in women

Active bacterial infection at the HELEF site

Incarcerated persons

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Intranasal povidone-iodine (PDI Profend) is applied to the patients' noses 60 minutes before surgery and approximately 12 hours after the first application.

1 day

2 applications (in-person)

Follow-up

Participants are monitored for surgical site infections and other complications for 6 months after the initial surgical procedure.

6 months

Routine visit at 6 months, additional contact attempts if necessary

Treatment Details

Interventions

• Povidone-Iodine Topical Ointment (Antiseptic)

Trial Overview The study is testing if povidone-iodine ointment in the nose reduces surgical site infections after orthopedic surgeries for serious lower extremity fractures. The focus is on preventing infections caused by Staphylococcus aureus bacteria.

Participant Groups

Group I: Nasal Povidone-Iodine Decolonization Intervention Experimental Treatment 1 Intervention

Intranasal povidone-iodine (PDI Profend) will be applied to the patients' noses 60 minutes before surgery to repair HELEF and approximately 12 hours after the first application. If the patient will have additional HELEF repair in the 6 month followup period, intranasal PVI will be applied in a similar manner for each procedure.

Group II: Concurrent Control Active Control 1 Intervention

Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.

Povidone-Iodine Topical Ointment is already approved in China for the following indications:

Approved in China as Povidone-Iodine Topical Ointment for:

• Preoperative skin preparation
• Wound care
• Surgical site infection prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Washington University Saint Louis, MO

University of Indiana Indianapolis, IN

University of Texas Southwestern Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Loreen Herwaldt

Lead Sponsor

Trials

1

Recruited

2,000+

Emory University

Collaborator

Trials

1735

Recruited

2,605,000+

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

PDI Healthcare

Collaborator

Trials

1

Recruited

2,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Dr. Jacqualyn A. Fouse

University of Texas

Chief Executive Officer since 2019

Ph.D. in Finance from the University of Texas at Arlington

Dr. Olukotun

University of Texas

Chief Medical Officer since 2020

MD from Albert Einstein College of Medicine

University of Utah

Collaborator

Trials

1169

Recruited

1,623,000+

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Dr. Susan Monarez

Centers for Disease Control and Prevention

Chief Executive Officer

PhD

Dr. Debra Houry

Centers for Disease Control and Prevention

Chief Medical Officer

MD, MPH

Washington University School of Medicine

Collaborator

Trials

2027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Indiana University

Collaborator

Trials

1063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Findings from Research

Liposomal formulations of povidone-iodine (PVP-I) are significantly less toxic to blood vessels compared to traditional aqueous PVP-I formulations, as demonstrated in a study using chick embryo models.

The study showed that liposomal PVP-I formulations reduced angiotoxic effects, such as coagulation and hemorrhages, indicating a safer option for local anti-infective treatments, especially in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative testing of liposomal and aqueous formulations of povidone-iodine for their angioirritative potential at the chorioallantoic membrane of ex ovo cultivated chick embryos. Wutzler, P., Sauerbrei, A., Härtl, A., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of povidone-iodine in pre-operative skin preparation. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Pilot Study to Evaluate the Adjunct Use of a Povidone-Iodine Topical Antiseptic in Patients with Soft Tissue Abscesses. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of dermal toxicity and toxicokinetics of povidone‑iodine in Göttingen minipigs. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative testing of liposomal and aqueous formulations of povidone-iodine for their angioirritative potential at the chorioallantoic membrane of ex ovo cultivated chick embryos. [2017]

8. Italy pubmed.ncbi.nlm.nih.gov

An unusual complication of late onset allergic contact dermatitis to povidone iodine in oral & maxillofacial surgery - a report of 2 cases. [2017]