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

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
  Activation of the accelerated flap pathway with a goal flap time of \<72h from injury
• Standard of Care Flap Timing — PROCEDURE
  Flap timing at the standard of care timing for the clinical site

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

First listed

Sep 18, 2026

Start date

Jan 1, 2027

Status verified

Sep 2026

Primary completion

Jul 31, 2030

Completion

Dec 31, 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

• Lily Mundy, MD
  (410)706-2492
  [email protected]

Locations (31)

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