Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

15 september 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

356

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Lily Mundy, MD
  • Telefoonnummer: (410)706-2492
  • E-mail: lmundy3@jhu.edu

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Versnelde flapdekking
Versnelde timing van flapoperaties met een doel van binnen 72 uur na het letsel. De behandeling van de fractuur of dislocatie, de selectie van de flap en het beheer van de flap na het letsel zullen ter beoordeling van de opererende chirurgen zijn en voor beide behandelingsgroepen worden gedocumenteerd.
Procedure: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Actieve vergelijker: Zorgstandaard Kleptiming
De flapoperatie wordt uitgevoerd volgens de standaardzorgtiming van de instelling. De behandeling van de fractuur of dislocatie, de selectie van de flap en het beheer van de flap na het letsel zullen ter beoordeling van de opererende chirurgen zijn en voor beide behandelingsgroepen worden gedocumenteerd.
Procedure: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Status
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mortality
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Johns Hopkins University

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Lily HMIR Mundy, MD, Johns Hopkins University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 juli 2030

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

15 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 september 2026

Eerst geplaatst (Werkelijk)

18 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00525377
  • 1UG3AR085896 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren