Using nasal povidone-iodine to prevent infections after orthopedic surgery
Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus Aureus Surgical Site Infections After Operative Procedures to Fix High-Energy Lower Extremity Fractures (POTENT Study)
This study is testing if putting povidone-iodine in the noses of patients having surgery for serious leg fractures can help prevent infections after the operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 6 sites (Atlanta, Georgia and 5 other locations) |
| Trial ID | NCT05763602 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if applying povidone-iodine (PVI) to the noses of patients undergoing orthopedic fixation for high-energy lower extremity fractures can reduce the risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus. Patients will receive PVI treatment within 60 minutes before surgery and again approximately 12 hours post-surgery. The study will track patient outcomes for six months following their procedures, including any signs or treatments for SSI. Data will be collected from medical records and follow-up visits to assess the effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing surgical procedures for high-energy lower extremity fractures.
Not a fit: Patients not undergoing the specified orthopedic procedures or those with contraindications to povidone-iodine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections in high-risk orthopedic patients.
How similar studies have performed: Previous studies have shown promise in using topical antiseptics to reduce infection rates, but this specific application of PVI in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years of age. * Is undergoing one or more procedures to address the included fractures listed below for one or more (at least one) HELEF at high-risk for SSI: * Open tibia fractures * Open femur fractures * Open or closed tibial plateau fractures * Open or closed tibial pilon fractures * Open or closed calcaneus fractures * Open or closed talus fractures * Open or closed foot fractures of any bone EXCEPT the toes * Open fibula fractures * Open rotational ankle fractures (malleoli) * Open or closed leg fractures associated with compartment syndrome * Examples of included procedures: * Excisional debridement of open fracture, femur and/or tibia * Intramedullary nail, tibia (open injury) * Intramedullary nail, femur (open injury) * Open reduction Pilon/Plafond fracture * Open reduction tibial plateau fracture * Open reduction calcaneal fracture * Open reduction Lisfranc/metatarsal associated with crush injury * Open reduction talus * External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome * Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture * Lower extremity amputation related to HELEF Exclusion Criteria: * Documented or verbalized sensitivity or allergy to iodine or iodine-based contrast. * Known pregnancy in women. * Active bacterial infection at the HELEF site. * Incarcerated persons. * Persons who cannot follow up at the participating site (e.g., people who are homeless at the time of the injury or people with intellectual challenges who lack the social support for follow up visits). * Patients with facial fractures or other conditions that preclude nasal swabbing. * Patients who do not speak English or Spanish.
Where this trial is running
Atlanta, Georgia and 5 other locations
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- University of Indiana — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Not_yet_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Loreen Herwaldt, MD — University of Iowa
- Study coordinator: Loreen Herwaldt, MD
- Email: loreen-herwaldt@uiowa.edu
- Phone: +1 319 356 0474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.