drugset / Trial / NCT05763602
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Phase 4
Active not recruiting
2000 enrolled
Loreen Herwaldt
Centers for Disease Control and Prevention · collabEmory University · collabIndiana University · collabPDI Healthcare · collabUniversity of Texas · collabUniversity of Utah · collabWashington University School of Medicine · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-09-15
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | — | Intranasal |
Indications
No indication recorded.