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

2026년 9월 15일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

356

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Lily Mundy, MD
  • 전화번호: (410)706-2492
  • 이메일: lmundy3@jhu.edu

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 가속화된 플랩 커버리지
부상 후 72시간 이내를 목표로 피판 수술 시기를 앞당깁니다. 골절 또는 탈구 관리, 플랩 선택 및 부상 후 플랩 관리는 수술 외과 의사의 재량에 따라 이루어지며 두 치료 그룹 모두에 대해 문서화됩니다.
절차: Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
활성 비교기: 치료 플랩 타이밍 표준
플랩 수술은 해당 기관의 표준 진료 시기에 맞춰 시행됩니다. 골절 또는 탈구 관리, 플랩 선택 및 부상 후 플랩 관리는 수술 외과 의사의 재량에 따라 이루어지며 두 치료 그룹 모두에 대해 문서화됩니다.
절차: Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical Status
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Mortality
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Johns Hopkins University

협력자

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

수사관

  • 수석 연구원: Lily HMIR Mundy, MD, Johns Hopkins University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2030년 7월 1일

연구 완료 (추정된)

2030년 12월 1일

연구 등록 날짜

최초 제출

2026년 9월 15일

QC 기준을 충족하는 최초 제출

2026년 9월 15일

처음 게시됨 (실제)

2026년 9월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00525377
  • 1UG3AR085896 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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