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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06293469




Registration number
NCT06293469
Ethics application status
Date submitted
28/02/2024
Date registered
5/03/2024
Date last updated
8/11/2024

Titles & IDs
Public title
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Scientific title
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
Secondary ID [1] 0 0
IRB00434587
Universal Trial Number (UTN)
Trial acronym
FLAP ATTACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Tibia Fracture 0 0
Open Dislocation of Ankle 0 0
Extremity Fracture Lower 0 0
Extremity Injuries Lower 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Accelerated Flap Coverage Surgery
Treatment: Surgery - Standard of Care Flap Timing

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.


Treatment: Surgery: Accelerated Flap Coverage Surgery
Timing of the flap surgery is with a goal of 72 hours from injury

Treatment: Surgery: Standard of Care Flap Timing
Timing of the flap surgery is the standard of care flap timing for the participating institution.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical status
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
6 months and 12 months
Secondary outcome [2] 0 0
Amputation
Timepoint [2] 0 0
6 months and 12 months
Secondary outcome [3] 0 0
Unplanned re-operation
Timepoint [3] 0 0
6 months and 12 months
Secondary outcome [4] 0 0
Number of days in hospital
Timepoint [4] 0 0
6 months and 12 months
Secondary outcome [5] 0 0
Quality of life as assessed by the Limb-Q
Timepoint [5] 0 0
6 months and 12 months

Eligibility
Key inclusion criteria
The inclusion criteria are:

1. Patients 18 years of age or older.
2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
3. Will have all planned flap surgeries performed by a participating surgeon or delegate.
4. Able to be randomized within 48 hours of injury.

The exclusion criteria are:

1. Site is unable to implement the accelerated flap protocol due to local logistics.
2. Primary amputation anticipated prior to attempted flap for management of the injury.
3. Critical limb ischemia that requires re-vascularization for limb perfusion.
4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
5. Burns at the musculoskeletal injury site.
6. Incarceration.
7. Currently enrolled in a trial that does not permit co-enrollment.
8. Declined to provide informed consent.
9. Unable to obtain informed consent due to language barriers.
10. Unable to obtain informed consent because a legally authorized representative was unavailable.
11. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
12. Prior enrollment in the trial.
13. Other reason to exclude the patient, as approved by the Methods Centre.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
356
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Other
Name
Johns Hopkins University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
McMaster University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Maryland, Baltimore
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Orthopaedic Trauma Association
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Foundation of Orthopedic Trauma
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06293469
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lily Mundy, MD
Address 0 0
Johns Hopkins School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lily Mundy, MD
Address 0 0
Country 0 0
Phone 0 0
410-706-2492
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06293469