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

• Status: Recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loreen Herwaldt
• Collaborators: Centers for Disease Control and Prevention; Emory University; Indiana University; PDI Healthcare; University of Texas; University of Utah; Washington University School of Medicine
• Treatments: Povidone; Povidone-Iodine

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 cannot consent, including patients with dementia, delirium, coma, impaired mental status, traumatic brain injury, and patients who are sedated or intubated.

• Closed, isolated rotational ankle fractures

• Patients who do not speak English or Spanish