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

15. september 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

356

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Lily Mundy, MD
  • Telefonnummer: (410)706-2492
  • E-post: lmundy3@jhu.edu

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Akselerert klaffdekning
Akselerert timing av klaffkirurgi med et mål på innen 72 timer fra skade. Håndtering av bruddet eller dislokasjonen, valg av klaff og håndtering av klaff etter skade vil være etter de opererende kirurgenes skjønn og dokumentert for begge behandlingsgruppene.
Fremgangsmåte: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Aktiv komparator: Standard of Care klafftiming
Klaffoperasjonen vil bli utført på standard pleietidspunkt for institusjonen. Håndtering av bruddet eller dislokasjonen, valg av klaff og håndtering av klaff etter skade vil være etter de opererende kirurgenes skjønn og dokumentert for begge behandlingsgruppene.
Fremgangsmåte: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Status
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. juli 2030

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

15. september 2026

Først innsendt som oppfylte QC-kriteriene

15. september 2026

Først lagt ut (Faktiske)

18. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00525377
  • 1UG3AR085896 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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