Open Tibia FractureFLAP ATTACKNCT06293469
Accelerated Flap Coverage in Severe Lower Extremity Trauma
A study testing Accelerated Flap Coverage Surgery in people with Open Tibia Fracture and Open Dislocation of Ankle, run by Johns Hopkins University at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower
- What is being tested?
- Accelerated Flap Coverage Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 4 Nov 2024to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria are:
- Patients 18 years of age or older.
- Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
- Will have all planned flap surgeries performed by a participating surgeon or delegate.
- Able to be randomized within 48 hours of injury.
The exclusion criteria are:
- Site is unable to implement the accelerated flap protocol due to local logistics.
- Primary amputation anticipated prior to attempted flap for management of the injury.
- Critical limb ischemia that requires re-vascularization for limb perfusion.
- Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
- Burns at the musculoskeletal injury site.
- Incarceration.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a trial that does not permit co-enrollment.
- Declined to provide informed consent.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative was unavailable.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Eligible patient or LAR was not approached within screening window (missed participant).
- Other reason to exclude the patient, as approved by the Principal Investigators.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
United States7 sites, 7 recruiting
- Recruiting
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Mark J Gage, MD
Mark J Gage, MD
- Recruiting
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Lily R Mundy, MD
Lily R Mundy, MD
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Lily R Mundy, MD
Lily R Mundy, MD
- Recruiting
University of Maryland Capital Region Medical Center
Largo, Maryland, 20774
Todd Jaeblon, MD
Todd Jaeblon, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lauren M Tatman, MD
Lauren M Tatman, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Graham J DeKeyser, MD
Graham J DeKeyser, MD
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Ara A Salibian, MD
Ara A Salibian, MD
Canada2 sites, 2 recruiting
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Alison Wong, MD, 506-648-6000, alison.wong@dal.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1
David Stockton, MD, 604-875-4111, david.stockton@vch.ca
Australia1 site, 1 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Lipi Shukla, MBBS, PhD
Lipi Shukla, MBBS, PhD
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Jordi Tomás-Hernández, MD
Antonio Bulla, MD, PhD
About this study
Official title: Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
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.
Read the 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.
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Being tested
- Accelerated Flap Coverage Surgery, Standard of Care Flap Timing
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Flap Coverage SurgeryProcedure or surgery
Timing of the flap surgery is with a goal of 72 hours from injury
Standard of Care Flap TimingProcedure or surgery
Timing of the flap surgery is the standard of care flap timing for the participating institution.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Flap Coverage | Experimental | 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. Receives: Procedure: Accelerated Flap Coverage Surgery |
| Standard of Care Flap Timing | Active comparator | 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. Receives: Procedure: Standard of Care Flap Timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status
Clinical status is a hierarchical composite of the following outcomes:
- All-cause mortality
- Amputation related to injury
- Re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure)
- Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)
Measured: 6 months
Secondary outcomes (7)
Mortality
All-cause mortality. Mortality will be time-to-event, with the assumption that earlier is worse than later.
Measured: 6 months and 12 months
Amputation
Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later.
Measured: 6 months and 12 months
Unplanned re-operation
Unplanned re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure). Re-operation for infection and major flap complication will account for more than one operation, assuming that more operations are worse.
Measured: 6 months and 12 months
Number of days in hospital
Days in an acute in-patient hospital (i.e., not rehab or nursing facility)
Measured: 6 months and 12 months
Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)
Patient-reported health status as assessed by the EQ-5D-5L. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents "the worst health you can imagine to 100 mm which represents "the best health you can imagine".
Measured: 6 months and 12 months
Quality of life as assessed by the Limb-Q
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.
Measured: 6 months and 12 months
Clinical Status
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start4 Nov 2024
- Primary completionAug 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Tibia FractureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of Maryland, Baltimore, Orthopaedic Trauma Association, Foundation of Orthopedic Trauma, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Lily Mundy, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293469
- Sponsor's protocol ID
- IRB00434587
- Acronym
- FLAP ATTACK
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
- ClinicalTrials.gov ID
- NCT06293469
- Acronym / sponsor ID
- FLAP ATTACK / IRB00434587
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- McMaster University, University of Maryland, Baltimore, Orthopaedic Trauma Association, Foundation of Orthopedic Trauma, Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Flap Coverage | Experimental | Procedure: Accelerated Flap Coverage SurgeryAccelerated 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 | Active comparator | Procedure: Standard of Care Flap TimingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Flap Coverage SurgeryTiming of the flap surgery is with a goal of 72 hours from injury | Procedure or surgery | Accelerated Flap Coverage |
| Standard of Care Flap TimingTiming of the flap surgery is the standard of care flap timing for the participating institution. | Procedure or surgery | Standard of Care Flap Timing |
Primary outcome
Clinical status
Time frame: 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)
7 secondary outcomes
Mortality
Time frame: 6 months and 12 months
Amputation
Time frame: 6 months and 12 months
Unplanned re-operation
Time frame: 6 months and 12 months
Number of days in hospital
Time frame: 6 months and 12 months
Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)
Time frame: 6 months and 12 months
Quality of life as assessed by the Limb-Q
Time frame: 6 months and 12 months
Clinical Status
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lily Mundy, MD principal investigator
Johns Hopkins School of Medicine
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Flap Coverage Surgery in people with Open Tibia Fracture and Open Dislocation of Ankle, run by Johns Hopkins University at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily Mundy, MD (410-706-2492, LMundy3@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.