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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06293469
Eligibility Criteria:
The inclusion criteria are:
1. Patients 18 years of age or older.
2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
3. Will have all planned flap surgeries performed by a participating surgeon or delegate.
4. Able to be randomized within 48 hours of injury.
The exclusion criteria are:
1. Site is unable to implement the accelerated flap protocol due to local logistics.
2. Primary amputation anticipated prior to attempted flap for management of the injury.
3. Critical limb ischemia that requires re-vascularization for limb perfusion.
4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
5. Burns at the musculoskeletal injury site.
6. Incarceration.
7. Expected injury survival of less than 12 months.
8. Terminal illness with expected survival of less than 12 months.
9. Currently enrolled in a trial that does not permit co-enrollment.
10. Declined to provide informed consent.
11. Unable to obtain informed consent due to language barriers.
12. Unable to obtain informed consent because a legally authorized representative was unavailable.
13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
14. Prior enrollment in the trial.
15. Eligible patient or LAR was not approached within screening window (missed participant).
16. Other reason to exclude the patient, as approved by the Principal Investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06293469
Study Brief:
Protocol Section:
NCT06293469