Accelerated Flap Coverage in Severe Lower Extremity Trauma

Part of paid clinical trials in Sacramento, California.

Sponsor
Johns Hopkins University
Study ID
NCT06293469
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Accelerated Flap Coverage Surgery — PROCEDURE
    Timing of the flap surgery is with a goal of 72 hours from injury
  • Standard of Care Flap Timing — PROCEDURE
    Timing of the flap surgery is the standard of care flap timing for the participating institution.

Study Details

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).

Key Dates

Start date
Nov 4, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Clinical status [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Ara A Salibian, MD
Ara A Salibian, MD (PRINCIPAL_INVESTIGATOR)
Augustine M Saiz, MD (PRINCIPAL_INVESTIGATOR)
John Hopkins Bayview Medical CenterBaltimoreMaryland21224
Lily R Mundy, MD
Lily R Mundy, MD (PRINCIPAL_INVESTIGATOR)
R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Mark J Gage, MD
Mark J Gage, MD (PRINCIPAL_INVESTIGATOR)
The Johns Hopkins HospitalBaltimoreMaryland21287
Lily R Mundy, MD
Lily R Mundy, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Capital Region Medical CenterLargoMaryland20774
Todd Jaeblon, MD
Todd Jaeblon, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Graham J DeKeyser, MD
Graham J DeKeyser, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Lauren M Tatman, MD
Lauren M Tatman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
UC Davis Medical Center· Sacramento, CAJohn Hopkins Bayview Medical Center· Baltimore, MDR Adams Cowley Shock Trauma Center· Baltimore, MDThe Johns Hopkins Hospital· Baltimore, MDUniversity of Maryland Capital Region Medical Center· Largo, MDOregon Health & Science University· Portland, OR

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