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Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries (FLAP ATTACK)

15 de septiembre de 2026 actualizado por: Johns Hopkins University
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).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

356

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Lily Mundy, MD
  • Número de teléfono: (410)706-2492
  • Correo electrónico: lmundy3@jhu.edu

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85006
        • Banner - University Medical Center Phoenix
        • Contacto:
    • California
      • Los Angeles, California, Estados Unidos, 90033
      • Los Angeles, California, Estados Unidos, 90033
        • Los Angeles Medical Center
        • Contacto:
      • Los Angeles, California, Estados Unidos, 90084
        • Cedars-Sinai Medical Center
        • Contacto:
          • Geoffrey Marecek, MD
          • Número de teléfono: 310-423-3277
          • Correo electrónico: gmarecek@gmail.com
      • Sacramento, California, Estados Unidos, 95817
        • UC Davis Medical Center
        • Contacto:
      • San Diego, California, Estados Unidos, 92121
        • UC San Diego Health
        • Contacto:
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale New Haven Hospital
        • Contacto:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Medicine
        • Contacto:
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • IU Health University Hospital
        • Contacto:
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Louisiana State University Health Sciences Center
        • Contacto:
          • Jessica Rivera, MD
          • Número de teléfono: 504-568-4808
          • Correo electrónico: jrive5@lsuhsc.edu
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins Hospital
        • Contacto:
          • Lily Mundy
          • Número de teléfono: 410-706-2492
          • Correo electrónico: LMundy3@jhu.edu
      • Baltimore, Maryland, Estados Unidos, 21201
        • University of Maryland - Shock Trauma Center
        • Contacto:
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopkins Hospital - Bayview Medical Center
        • Contacto:
          • Lily Mundy, MD
          • Número de teléfono: 410-550-0100
          • Correo electrónico: lmundy3@jhu.edu
      • Largo, Maryland, Estados Unidos, 20774
        • University of Maryland - Capital Region
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham and Women's Hospital
        • Contacto:
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39216
        • University of Mississippi Medical Center
        • Contacto:
          • Patrick Bergin, MD
          • Número de teléfono: 601-984-1000
          • Correo electrónico: PBergin@umc.edu
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198
        • University of Nebraska Medical Center
        • Contacto:
          • Andrew Hollins, MD
          • Número de teléfono: 402-559-4000
          • Correo electrónico: ahollins@unmc.edu
    • New York
      • The Bronx, New York, Estados Unidos, 11418
        • Jamaica Hospital Medical Center
        • Contacto:
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • University of Cincinnati Medical Center
        • Contacto:
      • Columbus, Ohio, Estados Unidos, 43221
        • Ohio State University Wexner Medical Center
        • Contacto:
      • Dayton, Ohio, Estados Unidos, 45409
        • Miami Valley Hospital
        • Contacto:
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University
        • Contacto:
          • Graham DeKeyser, MD
          • Número de teléfono: 503-494-8311
          • Correo electrónico: dekeyser@ohsu.edu
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Brown University Health
        • Contacto:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • The University of Texas Health Science Center at Houston
        • Contacto:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah Hospital
        • Contacto:
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • INOVA Fairfax Hospital
        • Contacto:
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • UW Medical Center
        • Contacto:
          • Jeffrey Friedrich, MD
          • Número de teléfono: 206-598-3300
          • Correo electrónico: jfriedri@uw.edu
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • University of Wisconsin Health University Hospital
        • Contacto:
          • Christopher Domes, MD
          • Número de teléfono: 608-263-6400
          • Correo electrónico: domes@ortho.wisc.edu
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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.
  • Treating surgeon is willing to comply with treatment allocation.
  • Able to be randomized within 72 hours of injury.

Exclusion Criteria:

  • 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 (LAR) 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cobertura de colgajo acelerada
Se aceleró el tiempo de la cirugía de colgajo con un objetivo de dentro de las 72 horas posteriores a la lesión. El manejo de la fractura o dislocación, la selección del colgajo y el manejo del colgajo posterior a la lesión quedarán a discreción de los cirujanos operadores y documentados para ambos grupos de tratamiento.
Procedimiento: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Comparador activo: Tiempo estándar de atención del colgajo
La cirugía del colgajo se realizará en el horario de atención estándar de la institución. El manejo de la fractura o dislocación, la selección del colgajo y el manejo del colgajo posterior a la lesión quedarán a discreción de los cirujanos operadores y documentados para ambos grupos de tratamiento.
Procedimiento: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Status
Periodo de tiempo: 6 months
Clinical status is a hierarchical composite of the following outcomes: 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)
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortality
Periodo de tiempo: 6 and 12 months
All-cause mortality. Mortality will be time-to-event, with the assumption that earlier is worse than later.
6 and 12 months
Amputation
Periodo de tiempo: 6 and 12 months
Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later.
6 and 12 months
Unplanned re-operation
Periodo de tiempo: 6 and 12 months
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 account for more than one operation, with the assumption that more is worse than less.
6 and 12 months
Number of days in hospital
Periodo de tiempo: 6 and 12 months
Days in an acute in-patient hospital (i.e., not rehab or nursing facility)
6 and 12 months
Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)
Periodo de tiempo: 6 and 12 months
Patient-reported health status as assessed by the EQ-5D-5L. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents "the worst health you can imagine to 100 mm which represents "the best health you can imagine."
6 and 12 months
Quality of life as assessed by the Limb-Q
Periodo de tiempo: 6 and 12 months
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 and 12 months
Clinical Status
Periodo de tiempo: 12 months
Clinical status is a hierarchical composite of the following outcomes: 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)
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Johns Hopkins University

Colaboradores

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigadores

  • Investigador principal: Lily HMIR Mundy, MD, Johns Hopkins University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de julio de 2030

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00525377
  • 1UG3AR085896 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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