Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06293469 · ClinicalTrials.gov registry record · NA
Accelerated Flap Coverage in Severe Lower Extremity Trauma
A NA study of Open Tibia Fracture and Open Dislocation of Ankle, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 356
- Enrollment target
- 9
- Study locations
NCT06293469 is a NA study of Open Tibia Fracture and Open Dislocation of Ankle that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 356 participants. The trial reports 9 study locations across 6 states.
The verdict
NCT06293469, a NA study of Open Tibia Fracture and Open Dislocation of Ankle, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 356 participants
- Enrollment target
- 9
- Study locations
Study 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 Studied
Interventions
- PROCEDURE Accelerated Flap Coverage Surgery
- PROCEDURE Standard of Care Flap Timing
Study Locations (9)
Maryland
- R Adams Cowley Shock Trauma Center - Baltimore
- John Hopkins Bayview Medical Center - Baltimore
- The Johns Hopkins Hospital - Baltimore
- University of Maryland Capital Region Medical Center - Largo
California
- UC Davis Medical Center - Sacramento
Oregon
- Oregon Health & Science University - Portland
Tennessee
- Vanderbilt University Medical Center - Nashville
Victoria
- The Alfred Hospital - Melbourne
Other
- Vall d'Hebron University Hospital - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2030-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06293469
The ClinicalTrials.gov registry entry for NCT06293469 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 356 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Open Tibia Fracture appearing as the primary indexed condition, and to 2 interventions - of which Accelerated Flap Coverage Surgery is the first listed.
NCT06293469 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Maryland, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT06293469 about?
NCT06293469 is a clinical study titled "Accelerated Flap Coverage in Severe Lower Extremity Trauma". 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 ei...
What is the current status of trial NCT06293469?
This trial is currently recruiting. It is a NA study. The enrollment target is 356 participants. The study started on 2024-11-04. Estimated completion is 2030-02.
What conditions does trial NCT06293469 study?
This clinical trial studies the following conditions: Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower.
What interventions are being tested in trial NCT06293469?
The interventions under investigation include: Accelerated Flap Coverage Surgery (PROCEDURE), Standard of Care Flap Timing (PROCEDURE).
Who is sponsoring clinical trial NCT06293469?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06293469 being conducted?
This trial has 9 study locations across California, Maryland, Oregon, Tennessee, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Open Tibia Fracture
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.