Accelerated Flap Coverage in Severe Lower Extremity Trauma

NCT06293469 | Recruiting DMC

• 1 other identifier: IRB00434587
• Study Type: interventional
• Target: 356
• Locations: 3 countries
• Sites: 9

Brief Summary

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).

Conditions

Open Tibia Fracture; Open Dislocation of Ankle; Extremity Fracture Lower; Extremity Injuries Lower

Outcome Measures

Primary Outcomes (1)

• Clinical status

  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) 4. Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)

  6 months

Secondary Outcomes (6)

• Mortality

  6 months and 12 months

• Amputation

  6 months and 12 months

• Unplanned re-operation

  6 months and 12 months

• Number of days in hospital

  6 months and 12 months

• Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)

  6 months and 12 months

Study Arms (2)

Accelerated Flap Coverage

EXPERIMENTAL

Accelerated flap surgery timing at a goal of within 72 hours from injury. 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.

Procedure: Accelerated Flap Coverage Surgery

Standard of Care Flap Timing

ACTIVE COMPARATOR

The flap surgery will be performed at the standard of care timing for the institution. 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.

Procedure: Standard of Care Flap Timing

Interventions

Accelerated Flap Coverage Surgery PROCEDURE

Timing of the flap surgery is with a goal of 72 hours from injury

Accelerated Flap Coverage

Standard of Care Flap Timing PROCEDURE

Timing of the flap surgery is the standard of care flap timing for the participating institution.

Standard of Care Flap Timing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Will have all planned flap surgeries performed by a participating surgeon or delegate.
• Able to be randomized within 48 hours of injury.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• McMaster University: collaborator
• University of Maryland, Baltimore: collaborator
• Orthopaedic Trauma Association: collaborator
• Foundation of Orthopedic Trauma: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (9)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

John Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

University of Maryland Capital Region Medical Center

Largo, Maryland, 20774, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lily Mundy, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily Mundy, MD

CONTACT

410-706-2492; LMundy3@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

ES (1); US (7); AU (1)