NCT06293469 Accelerated Flap Coverage in Severe Lower Extremity Trauma
| NCT ID | NCT06293469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Open Tibia Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 356 participants in total. It began in 2024-11-04 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).
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.
Contact & Investigator
Lily Mundy, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06293469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Open Tibia Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06293469 currently recruiting?
Yes, NCT06293469 is actively recruiting participants. Contact the research team at LMundy3@jhu.edu for enrollment information.
Where is the NCT06293469 trial being conducted?
This trial is being conducted at Sacramento, United States, Baltimore, United States, Baltimore, United States, Baltimore, United States and 5 additional locations.
Who is sponsoring the NCT06293469 clinical trial?
NCT06293469 is sponsored by Johns Hopkins University. The principal investigator is Lily Mundy, MD at Johns Hopkins School of Medicine. The trial plans to enroll 356 participants.