Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT05763602
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05763602
Study Brief:
Protocol Section:
NCT05763602