Povidone-Iodine for Surgical Site Infection

(POTENT Trial)

Recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether applying povidone-iodine, an antiseptic, to patients' noses can reduce infections after surgeries on serious leg, ankle, or foot fractures. It specifically targets infections from the common bacteria Staphylococcus aureus. Some participants will receive this nasal treatment, while others will continue with standard care. Suitable candidates include those undergoing surgeries for certain serious leg or foot fractures who do not have an iodine allergy. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Povidone-Iodine Topical Ointment?

Research shows that povidone-iodine use in the nose is generally safe and well-tolerated. Studies indicate it can be applied in the nasal area for several months without issues. This practice helps lower the risk of infections after surgery, particularly those caused by bacteria like Staphylococcus aureus. Although povidone-iodine has not been studied as extensively as some other treatments, current evidence suggests it effectively reduces infections at surgical sites in orthopedic surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for surgical site infections involve antibiotics and antiseptic protocols. However, researchers are excited about using Povidone-Iodine because it offers a different approach by directly decolonizing bacteria in the nasal passages. This method targets the bacteria right where they often reside, potentially reducing the risk of infection before it starts. Furthermore, Povidone-Iodine is applied topically, which can minimize systemic side effects compared to oral antibiotics. Its quick application before surgery also ensures timely action against harmful bacteria.

What evidence suggests that povidone-iodine might be an effective treatment for surgical site infections?

Research shows that povidone-iodine (PVI) helps reduce infections after surgery. In this trial, one group of participants will receive a nasal povidone-iodine decolonization intervention, applying intranasal PVI before and after surgery. Studies have found that using PVI to clean the surgical area can lower the chances of infection, specifically highlighting its effectiveness against bacteria like Staphylococcus aureus. PVI is well-known for killing germs and reducing infection risk. Although results can vary, PVI is generally recommended for minimizing infections during surgery. ^{2 6 7 8 9}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38825398/

Effects of povidone-iodine wound irrigation on surgical site ... Thirty-day surgical site infections occurred in 100 (14%) patients-54 (16%) in the povidone-iodine group and 46 (13%) in the control group (odds ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2386220/

The efficacy and risks of using povidone-iodine irrigation to ... Of the 15 studies, 5 did not find povidone-iodine irrigation to be significantly more effective at preventing surgical site infection than the comparison ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2817941

Incisional Wound Irrigation for the Prevention of Surgical ... Incisional wound irrigation with aqueous antiseptic solutions was associated with a reduction in the risk of SSIs; results suggest that the use of antibiotic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589845023000118

Evaluation of the role of povidone‑iodine in the prevention ... Surgical site preparation with PVP-I leads to low surgical site infection (SSI) rates. •. PVP-I is recommended for intraoperative irrigation and decreases SSIs.

5. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(22)00187-2/fulltext

Efficacy of different preoperative skin antiseptics on ... Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7737406/

Preoperative Intranasal Decolonization with Topical ... One study, however, showed increased effectiveness in preventing SSI when topical intranasal povidone-iodine was combined with the use of ...

7. ajicjournal.org ajicjournal.org/article/S0196-6553(23)00073-1/fulltext

Nasal decolonization: What antimicrobials and antiseptics ... Povidone-iodine is less well-studied. Current data suggest that it decreases the risk of surgical site infections after orthopedic surgical procedures. In ...

8. journals.asm.org journals.asm.org/doi/10.1128/aac.00682-20

Povidone Iodine: Properties, Mechanisms of Action, and Role ... This article discusses povidone iodine (PVP-I) as an alternative decolonization agent and is based on literature reviewed during an expert's workshop on ...

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/0145561320932318

Povidone-Iodine Use in Sinonasal and Oral Cavities Povidone-iodine has been safely administered for up to 5 months in the nasal cavity and 6 months in the oral cavity. Concentrations less than ...