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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT06033534
Eligibility Criteria:
Inclusion Criteria:
* Open fractures of any type and location
* Fractures classified as Gustilo-Anderson Type I, II, IIIa, IIIb, IIIc
* Patients requiring surgical intervention for fracture correction
* Patients with no contraindications for antibiotic treatment
* Patients providing informed consent
Exclusion Criteria:
* Patients with active infections
* Patients with a history of allergies or adverse reactions to the antibiotics used in the extended-release device
* Patients with severe renal or hepatic insufficiency
* Non-cooperative patients or those who are unable to adhere to follow-up visits or study procedures due to physical or mental limitations or severe neurological illness
* Patients who have undergone spinal surgery
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT06033534
Study Brief:
Protocol Section:
NCT06033534