Accelerated Flap Coverage in Severe Lower Extremity Trauma

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

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

Interventions

PROCEDURE

Accelerated Flap Coverage Surgery

Timing of the flap surgery is with a goal of 72 hours from injury

PROCEDURE

Standard of Care Flap Timing

Timing of the flap surgery is the standard of care flap timing for the participating institution.

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• Orthopaedic Trauma Association

  collaborator OTHER

• Foundation of Orthopedic Trauma

  collaborator OTHER

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Lily Mundy, MD · Johns Hopkins School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-04

Primary Completion

2029-08-31

Completion

2030-02-28

Countries

• United States
• Australia
• Spain

Study Locations