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:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT06504992
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older at time of surgery
* Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).
* Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).
* Able to attend standard of care follow up for six months post-operatively
Exclusion Criteria:
* Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin.
* Patients who have already had definitive fracture fixation before enrollment in the study
* Patients with open fracture already infected at time of enrollment
* Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).
* Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)
* Patients who do not speak English
* Patients who are currently pregnant
* Patients who are unable to provide consent and do not have a substitute decision maker able to provide consent
* Patients who will have severe difficulty with follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06504992
Study Brief:
Protocol Section:
NCT06504992