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

15 september 2026 uppdaterad 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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

356

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Accelererad klafftäckning
Accelererad timing för flikkirurgi vid ett mål på inom 72 timmar från skadan. Hantering av frakturen eller dislokationen, val av klaff och hantering av klaff efter skada kommer att vara upp till de opererande kirurgernas gottfinnande och dokumenteras för båda behandlingsgrupperna.
Procedur: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Aktiv komparator: Standard of Care Flap Timing
Flikoperationen kommer att utföras enligt standardvårdens tidpunkt för institutionen. Hantering av frakturen eller dislokationen, val av klaff och hantering av klaff efter skada kommer att vara upp till de opererande kirurgernas gottfinnande och dokumenteras för båda behandlingsgrupperna.
Procedur: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical Status
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johns Hopkins University

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 januari 2027

Primärt slutförande (Beräknad)

1 juli 2030

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

15 september 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

18 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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