Accelerated Flap Coverage in Severe Lower Extremity Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accelerated Flap Coverage Surgery, Standard of Care Flap Timing.
- Who it may be relevant to
- Registry conditions: Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
Overview
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).
Detailed description
Infection following severe lower extremity musculoskeletal injuries is a challenging problem. Several factors hypothesized to influence infection have been explored and, in many cases, optimized or found not to be influential. A persistent area of uncertainty and variability is the timing of acute soft tissue coverage. In the United States, the mean time to coverage from injury is 10 days, and infection rates are 20-35%. In the United Kingdom, there are national guidelines to support coverage within 72 hours of injury, and infection rates are less than 10%. While the data to support early coverage is promising, the necessary evidence to make this significant change is lacking. To justify the mobilization of resources and expense required to shift practice, a definitive trial is needed. This trial seeks to fill this critical knowledge gap.
The primary objective of this trial is to determine if accelerated flap coverage (within 72 hours of injury) compared to standard flap coverage timing leads lower rates of infection and infection-related complications. The trial population includes patients 18 years and older with an acute open fracture and/or dislocation below the knee, with a diagnosed need for acute soft tissue coverage with a flap. Patients who undergo primary amputation prior to attempted flap coverage will be excluded. There will be 356 participants randomized in 1:1 ratio to receive either accelerated flap coverage (goal of flap within 72 hours from injury) or flap coverage at the time that reflects the standard of care at each institution. The timing of the trial interventions, other adjunctive treatments, the fracture fixation, and flap coverage procedures will be documented for both treatment groups. Management of the fracture or dislocation, selection of flap, and post-injury flap management will be at the discretion of the operating surgeons and documented for both treatment groups. Participants will have follow-up at 6 weeks, 3 months, 6 months, and 12 months post-randomization.
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). The secondary outcomes will independently assess the individual components of the primary outcome at 6 and 12 months, the composite outcome at 12 months, and health-related quality of life and patient satisfaction over 6 and 12 months. An Adjudication Committee will review primary and secondary endpoints and a Data Safety Monitoring Committee (DSMC) will review all safety events.
Interventions
- Procedure Accelerated Flap Coverage Surgery
Timing of the flap surgery is with a goal of 72 hours from injury - Procedure Standard of Care Flap Timing
Timing of the flap surgery is the standard of care flap timing for the participating institution.
Primary outcome measures
- Clinical status [Time frame: 6 months]
Secondary outcome measures (6)
- Mortality [Time frame: 6 months and 12 months]
- Amputation [Time frame: 6 months and 12 months]
- Unplanned re-operation [Time frame: 6 months and 12 months]
- Number of days in hospital [Time frame: 6 months and 12 months]
- Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L) [Time frame: 6 months and 12 months]
- Quality of life as assessed by the Limb-Q [Time frame: 6 months and 12 months]
Eligibility criteria
The inclusion criteria are:
- Patients 18 years of age or older.
- Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
- Will have all planned flap surgeries performed by a participating surgeon or delegate.
- Able to be randomized within 48 hours of injury.
The exclusion criteria are:
- Site is unable to implement the accelerated flap protocol due to local logistics.
- Primary amputation anticipated prior to attempted flap for management of the injury.
- Critical limb ischemia that requires re-vascularization for limb perfusion.
- Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
- Burns at the musculoskeletal injury site.
- Incarceration.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a trial that does not permit co-enrollment.
- Declined to provide informed consent.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative was unavailable.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Eligible patient or LAR was not approached within screening window (missed participant).
- Other reason to exclude the patient, as approved by the Principal Investigators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- UC Davis Medical Center — Sacramento
- R Adams Cowley Shock Trauma Center — Baltimore
- John Hopkins Bayview Medical Center — Baltimore
- The Johns Hopkins Hospital — Baltimore
- University of Maryland Capital Region Medical Center — Largo
- Oregon Health & Science University — Portland
- Vanderbilt University Medical Center — Nashville
Australia · 1 center
- The Alfred Hospital — Melbourne
Spain · 1 center
- Vall d'Hebron University Hospital — Barcelona
Identifiers
NCT: NCT06293469 · IRB00434587