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

2026年9月15日 更新者：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).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

356

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Lily Mundy, MD
  • 电话号码：(410)706-2492
  • 邮箱：lmundy3@jhu.edu

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：加速皮瓣覆盖
加速皮瓣手术时间，目标是在受伤后 72 小时内完成。 骨折或脱位的处理、皮瓣的选择以及受伤后皮瓣的处理将由手术外科医生决定并记录在两个治疗组中。
程序：Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
有源比较器：标准护理皮瓣计时
皮瓣手术将按照该机构的标准护理时间进行。 骨折或脱位的处理、皮瓣的选择以及受伤后皮瓣的处理将由手术外科医生决定并记录在两个治疗组中。
程序：Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Clinical Status
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johns Hopkins University

合作者

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

调查人员

  • 首席研究员：Lily HMIR Mundy, MD、Johns Hopkins University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2030年7月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年9月15日

首先提交符合 QC 标准的

2026年9月15日

首次发布 (实际的)

2026年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00525377
  • 1UG3AR085896 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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