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

15 septembre 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

356

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Lily Mundy, MD
  • Numéro de téléphone: (410)706-2492
  • E-mail: lmundy3@jhu.edu

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85006
    • California
      • Los Angeles, California, États-Unis, 90033
      • Los Angeles, California, États-Unis, 90033
      • Los Angeles, California, États-Unis, 90084
        • Cedars-Sinai Medical Center
        • Contact:
      • Sacramento, California, États-Unis, 95817
        • UC Davis Medical Center
        • Contact:
      • San Diego, California, États-Unis, 92121
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06510
        • Yale New Haven Hospital
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • University of Chicago Medicine
        • Contact:
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • IU Health University Hospital
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70112
        • Louisiana State University Health Sciences Center
        • Contact:
    • Maryland
      • Baltimore, Maryland, États-Unis, 21287
        • Johns Hopkins Hospital
        • Contact:
      • Baltimore, Maryland, États-Unis, 21201
        • University of Maryland - Shock Trauma Center
        • Contact:
      • Baltimore, Maryland, États-Unis, 21224
        • Johns Hopkins Hospital - Bayview Medical Center
        • Contact:
          • Lily Mundy, MD
          • Numéro de téléphone: 410-550-0100
          • E-mail: lmundy3@jhu.edu
      • Largo, Maryland, États-Unis, 20774
        • University of Maryland - Capital Region
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Brigham and Women's Hospital
        • Contact:
    • Mississippi
      • Jackson, Mississippi, États-Unis, 39216
        • University of Mississippi Medical Center
        • Contact:
          • Patrick Bergin, MD
          • Numéro de téléphone: 601-984-1000
          • E-mail: PBergin@umc.edu
    • Missouri
      • Columbia, Missouri, États-Unis, 65212
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68198
        • University of Nebraska Medical Center
        • Contact:
    • New York
      • The Bronx, New York, États-Unis, 11418
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • University of Cincinnati Medical Center
        • Contact:
      • Columbus, Ohio, États-Unis, 43221
        • Ohio State University Wexner Medical Center
        • Contact:
      • Dayton, Ohio, États-Unis, 45409
    • Oregon
      • Portland, Oregon, États-Unis, 97239
        • Oregon Health & Science University
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Houston, Texas, États-Unis, 77030
        • The University of Texas Health Science Center at Houston
        • Contact:
    • Utah
      • Salt Lake City, Utah, États-Unis, 84132
    • Virginia
      • Falls Church, Virginia, États-Unis, 22042
        • INOVA Fairfax Hospital
        • Contact:
    • Washington
      • Seattle, Washington, États-Unis, 98195
        • UW Medical Center
        • Contact:
          • Jeffrey Friedrich, MD
          • Numéro de téléphone: 206-598-3300
          • E-mail: jfriedri@uw.edu
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53792
        • University of Wisconsin Health University Hospital
        • Contact:
      • Milwaukee, Wisconsin, États-Unis, 53226

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Couverture accélérée des volets
Calendrier accéléré de la chirurgie du lambeau dans les 72 heures suivant la blessure. La prise en charge de la fracture ou de la luxation, la sélection du lambeau et la gestion du lambeau post-lésion seront à la discrétion des chirurgiens opératoires et documentés pour les deux groupes de traitement.
Procédure: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Comparateur actif: Synchronisation des lambeaux de soins standard
La chirurgie du lambeau sera réalisée selon les délais de soins standard de l'établissement. La prise en charge de la fracture ou de la luxation, la sélection du lambeau et la gestion du lambeau post-lésion seront à la discrétion des chirurgiens opératoires et documentés pour les deux groupes de traitement.
Procédure: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Clinical Status
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mortality
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Johns Hopkins University

Collaborateurs

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

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 juillet 2030

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

15 septembre 2026

Première soumission répondant aux critères de contrôle qualité

15 septembre 2026

Première publication (Réel)

18 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00525377
  • 1UG3AR085896 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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