Accelerated Flap Coverage in Severe Lower Extremity Trauma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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).

This is the vanguard and international part of the FLAP ATTACK trial.

Eligibility

Primary outcome measure(s)

• Clinical status — 6 months
  Clinical status is a hierarchical composite of the following outcomes: 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) 4. Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)

Trial sites (11)