PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) (NCT05763602) | Clinical Trial Compass
Active — Not RecruitingPhase 4
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
United States2,000 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fo…
What they're measuring
1
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
Timeframe: within 180 days of the initial surgical procedure for HELEF repair