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PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) - Trial NCT05763602

Access comprehensive clinical trial information for NCT05763602 through Pure Global AI's free database. This Phase 4 trial is sponsored by Loreen Herwaldt and is currently Recruiting. The study focuses on Surgical Site Infection. Target enrollment is 2000 participants.

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NCT05763602
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05763602
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PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus Aureus Surgical Site Infections After Operative Procedures to Fix High-Energy Lower Extremity Fractures (POTENT Study)

Study Focus

Surgical Site Infection

povidone-iodine topical ointment

Interventional

drug

Sponsor & Location

Loreen Herwaldt

University of Iowa

Atlanta,Indianapolis,Iowa City,Saint Louis,Dallas,Salt Lake City, United States of America

Timeline & Enrollment

Phase 4

Sep 15, 2022

May 31, 2025

2000 participants

Primary Outcome

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

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.

ICD-10 Classifications

Infection following a procedure, not elsewhere classified
Bacterial infection of unspecified site
Other bacterial infections of unspecified site
Infection of obstetric surgical wound
Other specified local infections of skin and subcutaneous tissue

Data Source

ClinicalTrials.gov

NCT05763602

Non-Device Trial