Extremity Fracture Lower Clinical Trial
— FLAP ATTACKOfficial title:
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
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).
Status | Not yet recruiting |
Enrollment | 356 |
Est. completion date | November 2029 |
Est. primary completion date | May 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. Currently enrolled in a trial that does not permit co-enrollment. 8. Declined to provide informed consent. 9. Unable to obtain informed consent due to language barriers. 10. Unable to obtain informed consent because a legally authorized representative was unavailable. 11. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 12. Prior enrollment in the trial. 13. Other reason to exclude the patient, as approved by the Methods Centre. |
Country | Name | City | State |
---|---|---|---|
Australia | The Alfred Hospital | Melbourne | Victoria |
Spain | Vall d'Hebron University Hospital | Barcelona | |
United States | John Hopkins Bayview Medical Center | Baltimore | Maryland |
United States | R Adams Cowley Shock Trauma Center | Baltimore | Maryland |
United States | The Johns Hopkins Hospital | Baltimore | Maryland |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Oregon Health & Science University | Portland | Oregon |
United States | UC Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Foundation of Orthopedic Trauma, McMaster University, Orthopaedic Trauma Association, University of Maryland, Baltimore |
United States, Australia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical status | Clinical status is a hierarchical composite of the following outcomes:
All-cause mortality Amputation related to injury Re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure) Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility) |
6 months | |
Secondary | Mortality | All-cause mortality | 6 months and 12 months | |
Secondary | Amputation | Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later. | 6 months and 12 months | |
Secondary | Unplanned re-operation | Unplanned re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure). Re-operation for infection and flap complication will be time-to-event, with the assumption that earlier is worse than later. Re-operation for infection and major flap complication will account for more than one operation, assuming that more operations are worse. | 6 months and 12 months | |
Secondary | Number of days in hospital | Days in an acute in-patient hospital (i.e., not rehab or nursing facility) | 6 months and 12 months | |
Secondary | Quality of life as assessed by the Limb-Q | Health-related quality of life and patient satisfaction measured with the Limb-Q. The Limb-Q is a set of independently functioning scales. All scales are scored 0-100 (higher = better). The Limb-Q Appearance, Physical, Symptoms, Financial Impact, Life Impact, and Psychological scales will be used. | 6 months and 12 months |
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