Povidone-Iodine for Surgical Site Infection

(POTENT Trial)

Recruiting at 5 trial locations

Overseen By Melissa A Ward, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Loreen Herwaldt

Disqualifiers: Iodine allergy, Pregnancy, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 day

2000 Participants Needed

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

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

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 United States, European Union, China for the following indications:

Approved in United States as Betadine for:

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

Approved in European Union as PVP-I for:

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

Approved in China as Povidone-Iodine Topical Ointment for:

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

Who Is Running the Clinical Trial?

Loreen Herwaldt

Lead Sponsor

Trials

1

Recruited

2,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

PDI Healthcare

Collaborator

Trials

1

Recruited

2,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Findings from Research

Povidone-iodine (PVP-I) is shown to be an effective antibacterial agent for preparing skin before surgical operations, based on cultures of microbial flora taken from the operation site.

The study involved comparing microbial cultures obtained pre-operatively and after the application of PVP-I, indicating its efficacy in reducing skin bacteria before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of povidone-iodine in pre-operative skin preparation. Georgiade, G., Riefkohl, R., Georgiade, N., et al.[2019]

In a study involving 105 patients undergoing cataract surgery, 5% povidone-iodine (PI) was found to be significantly more effective than 1% PI in reducing bacterial colonies on the conjunctiva, especially when initial bacterial loads were high.

While in vitro studies suggested that lower concentrations of PI might be more effective, this in vivo study demonstrated that 5% PI resulted in a greater reduction in bacterial counts, indicating its superior efficacy as a preoperative antiseptic.

NCBI (Pubmed)

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. Ferguson, AW., Scott, JA., McGavigan, J., et al.[2019]

In a study of 7566 patients undergoing open-heart surgery, the use of 10% povidone-iodine (PVP-I) for skin and wound disinfection resulted in a low incidence of severe infections, with only 0.5% experiencing deep sternal or retrosternal infections.

While superficial wound healing defects occurred in 5% of patients and were easily treatable with local PVP-I application, deep infections posed a significant risk, leading to a 40% mortality rate, highlighting the importance of strict aseptic techniques and effective antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. Klövekorn, WP., Meisner, H., Sebening, F.[2019]

Povidone-iodine (PVP-I) is an effective treatment for ocular infections, offering advantages such as a broader antibacterial spectrum, no observed bacterial resistance, and lower cost compared to other treatments.

PVP-I has been successfully used in various applications, including pre- and postoperative surgical prophylaxis and treatment of bacterial conjunctivitis, supported by studies conducted over the past 17 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. Isenberg, SJ., Apt, L., Campeas, D.[2017]

In a randomized controlled pilot study of adult patients with superficial skin abscesses, the addition of povidone-iodine (PVP-I) to standard incision and drainage (I&D) treatment did not significantly improve clinical cure rates, with 88.2% in the PVP-I group compared to 91.3% in the standard care group.

However, the PVP-I group experienced a significantly higher rate of adverse events (59.6%) compared to the standard care group (26.5%), primarily due to local skin irritation, indicating that while PVP-I may not enhance efficacy, it may increase the risk of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study to Evaluate the Adjunct Use of a Povidone-Iodine Topical Antiseptic in Patients with Soft Tissue Abscesses. Olson, AS., Rosenblatt, L., Salerno, N., et al.[2019]

A study on Göttingen Minipigs® showed that daily application of 7.5% and 10% povidone-iodine (PVP-I) for up to 39 weeks was safe, with no skin irritation or thyroid dysfunction observed.

Despite increased serum iodine levels, the treatment did not lead to endocrine disruption, suggesting that PVP-I could provide antimicrobial benefits in humans without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dermal toxicity and toxicokinetics of povidone‑iodine in Göttingen minipigs. Eddy, EP., Shet, MS., Cataldo, M., et al.[2023]

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]

Povidone iodine (PVP-I) is widely used as a pre-operative antiseptic, but there are rare cases of allergic reactions, as demonstrated in two patients who developed allergic contact dermatitis after its use.

While PVP-I is generally considered a low sensitizer, this case highlights the need for further evaluation of its potential to cause allergic reactions, suggesting that pre-operative allergy testing for PVP-I may be worth considering in some patients.

NCBI (Pubmed)

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. Reyazulla, MA., Gopinath, AL., Vaibhav, N., 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]