RecruitingNot ApplicableNCT06293469

Accelerated Flap Coverage in Severe Lower Extremity Trauma

Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries


Sponsor

Johns Hopkins University

Enrollment

356 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Accelerated Flap Coverage Surgery and a procedure called Standard of Care Flap Timing for people with extremity fracture lower, extremity injuries lower, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAccelerated Flap Coverage Surgery

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

PROCEDUREStandard of Care Flap Timing

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


Locations(9)

UC Davis Medical Center

Sacramento, California, United States

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

John Hopkins Bayview Medical Center

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Maryland Capital Region Medical Center

Largo, Maryland, United States

Oregon Health & Science University

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The Alfred Hospital

Melbourne, Victoria, Australia

Vall d'Hebron University Hospital

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT06293469


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