Condition: Open Tibia Fracture · Open Dislocation of Ankle · Extremity Fracture Lower · Sponsor: 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).
This description comes directly from the study's public registry record.
Lily Mundy, MD · 410-706-2492 · LMundy3@jhu.edu
Always discuss trial participation with your own doctor first.
| UC Davis Medical Center | Sacramento, California, United States | Recruiting |
| R Adams Cowley Shock Trauma Center | Baltimore, Maryland, United States | Recruiting |
| John Hopkins Bayview Medical Center | Baltimore, Maryland, United States | Recruiting |
| The Johns Hopkins Hospital | Baltimore, Maryland, United States | Recruiting |
| University of Maryland Capital Region Medical Center | Largo, Maryland, United States | Recruiting |
| Oregon Health & Science University | Portland, Oregon, United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
| The Alfred Hospital | Melbourne, Victoria, Australia | Recruiting |
| Vall d'Hebron University Hospital | Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06293469