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PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

NCT05763602 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-02-04

No results posted yet for this study

Summary

The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF) will decrease the patients' risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus.

Conditions

  • Surgical Site Infection

Interventions

DRUG

povidone-iodine topical ointment

Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • PDI Healthcare

    collaborator UNKNOWN

  • Centers for Disease Control and Prevention

    collaborator FED

  • Loreen Herwaldt

    lead OTHER

Principal Investigators

  • Loreen Herwaldt, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763602 on ClinicalTrials.gov