Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06293469

Conditions

Open Tibia Fracture

Open Dislocation of Ankle

Extremity Fracture Lower

Extremity Injuries Lower

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Accelerated Flap Coverage Surgery

Standard of Care Flap Timing

Study Details

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

Study ID

NCT06293469

Start date

Nov 4, 2024

Status verified date

Oct, 2025

Completion date

Feb, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

The inclusion criteria are:

1. Patients 18 years of age or older.
2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
3. Will have all planned flap surgeries performed by a participating surgeon or delegate.
4. Able to be randomized within 48 hours of injury.

The exclusion criteria are:

1. Site is unable to implement the accelerated flap protocol due to local logistics.
2. Primary amputation anticipated prior to attempted flap for management of the injury.
3. Critical limb ischemia that requires re-vascularization for limb perfusion.
4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
5. Burns at the musculoskeletal injury site.
6. Incarceration.
7. Expected injury survival of less than 12 months.
8. Terminal illness with expected survival of less than 12 months.
9. Currently enrolled in a trial that does not permit co-enrollment.
10. Declined to provide informed consent.
11. Unable to obtain informed consent due to language barriers.
12. Unable to obtain informed consent because a legally authorized representative was unavailable.
13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
14. Prior enrollment in the trial.
15. Eligible patient or LAR was not approached within screening window (missed participant).
16. Other reason to exclude the patient, as approved by the Principal Investigators.

Study Design

Enrollment

356 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated Flap Coverage

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.

active comparator: Standard of Care Flap Timing

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.

Interventions

Accelerated Flap Coverage Surgery

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

Standard of Care Flap Timing

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

Primary outcome measure

  • Clinical status [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lily Mundy, MD

410-706-2492LMundy3@jhu.edu

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Ara A Salibian, MD

R Adams Cowley Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Mark J Gage, MD

John Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Principal Investigator:

Lily R Mundy, MD

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Lily R Mundy, MD

University of Maryland Capital Region Medical Center

Recruiting

Largo, Maryland, United States, 20774

Principal Investigator:

Todd Jaeblon, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Graham J DeKeyser, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Lauren M Tatman, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-14.