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NCT05763602 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Surgical Site Infection, sponsored by Loreen Herwaldt.

Active
Registry status
Phase 4
Development phase
2,000
Enrollment target
6
Study locations

NCT05763602 is a Phase 4 study of Surgical Site Infection that is active but no longer recruiting, run by Loreen Herwaldt. The registered enrollment target is 2,000 participants, above the 488-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (310% higher). The trial reports 6 study locations across 6 states.

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The verdict

NCT05763602, a Phase 4 study of Surgical Site Infection, is active but no longer recruiting, sponsored by Loreen Herwaldt.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
2,000 participants
Enrollment target
6
Study locations

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 Studied

Surgical Site Infection

Interventions

  • DRUG povidone-iodine topical ointment

Study Locations (6)

Georgia

  • Emory University - Atlanta

Indiana

  • University of Indiana - Indianapolis

Iowa

  • University of Iowa - Iowa City

Missouri

  • Washington University - St Louis

Texas

  • University of Texas Southwestern - Dallas

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2022-09-15
Est. Completion 2026-05-31
Phase Phase 4

Sponsor

Loreen Herwaldt

1 total trials

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What the Registry Record Tells You About NCT05763602

The ClinicalTrials.gov registry entry for NCT05763602 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 488-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (310% higher). The listed sponsor is Loreen Herwaldt, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Surgical Site Infection appearing as the primary indexed condition, and to 1 intervention - of which povidone-iodine topical ointment is the first listed.

NCT05763602 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Georgia, Indiana, Iowa.

Frequently Asked Questions

What is clinical trial NCT05763602 about?

NCT05763602 is a clinical study titled "PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)". 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), par...

What is the current status of trial NCT05763602?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 2,000 participants. The study started on 2022-09-15. Estimated completion is 2026-05-31.

What conditions does trial NCT05763602 study?

This clinical trial studies the following conditions: Surgical Site Infection.

What interventions are being tested in trial NCT05763602?

The interventions under investigation include: povidone-iodine topical ointment (DRUG).

Who is sponsoring clinical trial NCT05763602?

This trial is sponsored by Loreen Herwaldt, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05763602 being conducted?

This trial has 6 study locations across Georgia, Indiana, Iowa, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.