← Back to Search

Antiseptic

Povidone-Iodine for Surgical Site Infection (POTENT Trial)

Phase 4

Recruiting

Led By Loreen Herwaldt, MD

Research Sponsored by Loreen Herwaldt

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 within 180 days of the initial surgical procedure for helef repair

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Povidone-iodine might cause local skin irritation or an allergic reaction in some people. However, since it's applied topically and not taken internally, systemic side effects are less common.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 180 days of the initial surgical procedure for helef repair

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 180 days of the initial surgical procedure for helef repair

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 180 days of the initial surgical procedure for helef repair for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)

Secondary study objectives

Clavien-Dindo assessment of postoperative complications scores

Incidence of all Complex SSI

Incidence of all Staphylococcus aureus SSI

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nasal Povidone-Iodine Decolonization InterventionExperimental Treatment1 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 ControlActive Control1 Intervention

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

Do I qualify?Apply below to find out