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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04403204
Eligibility Criteria:
Inclusion Criteria:
Established SSI Fracture (Cohort Cohort 1, Group 1)
1. Patients 18 years of age or older.
2. Extremity fracture.
3. Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
4. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.
5. Will have all fracture care surgeries performed by a participating surgeon or delegate.
6. Provision of informed consent.
Subset: DCE-MRI (Cohort 1-1, Group 2)
1. Patients 18 years of age or older.
2. Closed extremity fracture.
3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
4. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
5. Provision of informed consent.
Exclusion Criteria:
Established SSI Fracture Cohort (Cohort 1, Group 1)
1. Fracture of the hand.
2. Iodine allergy.
3. Received previous surgical debridement to manage the SSI.
4. Incarceration.
5. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
Subset: DCE-MRI (Cohort 1-1, Group2)
6. the presence of an electronic implant, such as a pacemaker
7. the presence of a metal implant, such as an aneurysm clip
8. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
9. A history of allergy to iodides
10. A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04403204
Study Brief:
Protocol Section:
NCT04403204