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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: Active Phase 4 study of Surgical Site Infection, sponsored by Loreen Herwaldt.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 4 |
What the registry record for NCT05763602 still lists
NCT05763602 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 488-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (310% higher).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Surgical Site Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05763602's enrollment target sits among peer trials
2,000 2nd of 25 the highest of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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