Accelerated Flap Coverage in Severe Lower Extremity Trauma

Not Applicable

Recruiting

• Conditions: Open Dislocation of Ankle; Extremity Fracture Lower; Extremity Injuries Lower; Open Tibia Fracture
• Interventions: Procedure: Accelerated Flap Coverage Surgery; Procedure: Standard of Care Flap Timing

• Registration Number: NCT06293469
• Lead Sponsor: Johns Hopkins University

Brief 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).

Detailed Description

Infection following severe lower extremity musculoskeletal injuries is a challenging problem. Several factors hypothesized to influence infection have been explored and, in many cases, optimized or found not to be influential. A persistent area of uncertainty and variability is the timing of acute soft tissue coverage. In the United States, the mean time to coverage from injury is 10 days, and infection rates are 20-35%. In the United Kingdom, there are national guidelines to support coverage within 72 hours of injury, and infection rates are less than 10%. While the data to support early coverage is promising, the necessary evidence to make this significant change is lacking. To justify the mobilization of resources and expense required to shift practice, a definitive trial is needed. This trial seeks to fill this critical knowledge gap.

The primary objective of this trial is to determine if accelerated flap coverage (within 72 hours of injury) compared to standard flap coverage timing leads lower rates of infection and infection-related complications. The trial population includes patients 18 years and older with an acute open fracture and/or dislocation below the knee, with a diagnosed need for acute soft tissue coverage with a flap. Patients who undergo primary amputation prior to attempted flap coverage will be excluded. There will be 356 participants randomized in 1:1 ratio to receive either accelerated flap coverage (goal of flap within 72 hours from injury) or flap coverage at the time that reflects the standard of care at each institution. The timing of the trial interventions, other adjunctive treatments, the fracture fixation, and flap coverage procedures will be documented for both treatment groups. 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. Participants will have follow-up at 6 weeks, 3 months, 6 months, and 12 months post-randomization.

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). The secondary outcomes will independently assess the individual components of the primary outcome at 6 and 12 months, the composite outcome at 12 months, and health-related quality of life and patient satisfaction over 6 and 12 months. An Adjudication Committee will review primary and secondary endpoints and a Data Safety Monitoring Committee (DSMC) will review all safety events.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Status Verified: 2024-11
• Study Start: 2024-11-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2029-08
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated Flap Coverage	Accelerated Flap Coverage Surgery	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.
Standard of Care Flap Timing	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 Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months and 12 months	All-cause mortality
Quality of life as assessed by the Limb-Q	6 months and 12 months	Health-related quality of life and patient satisfaction measured with the Limb-Q. The Limb-Q is a set of independently functioning scales. All scales are scored 0-100 (higher = better). The Limb-Q Appearance, Physical, Symptoms, Financial Impact, Life Impact, and Psychological scales will be used.
Amputation	6 months and 12 months	Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later.
Unplanned re-operation	6 months and 12 months	Unplanned re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure). Re-operation for infection and flap complication will be time-to-event, with the assumption that earlier is worse than later. Re-operation for infection and major flap complication will account for more than one operation, assuming that more operations are worse.
Number of days in hospital	6 months and 12 months	Days in an acute in-patient hospital (i.e., not rehab or nursing facility)

Trial Locations

Locations (8)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

R Adams Cowley Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

John Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain