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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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