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

Launched by LOREEN HERWALDT · Mar 6, 2023

Keywords

ClinConnect Summary

The POTENT Study is researching whether applying a special antiseptic called povidone iodine (PVI) to the noses of patients can help prevent infections after certain leg surgeries. These surgeries are for serious fractures in the lower leg, ankle, or foot, which are at high risk of becoming infected, especially by a bacteria called Staphylococcus aureus. The study is currently looking for participants aged 18 and older who will undergo these specific surgical procedures.

If you join the study, you'll be asked to apply PVI to your nose before your surgery. This could help reduce your risk of developing an infection afterward. To participate, you should have a high-energy fracture that requires surgery, but you can't have any allergies to iodine, be pregnant, or have an active infection at the surgery site. The study is open to all genders, and participants will need to follow up at the study site after their surgery to monitor their recovery. This trial aims to find out if this simple step can enhance safety during recovery from significant injuries.

Gender

ALL

Eligibility 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.