Open Tibia FractureFLAP ATTACKNCT07828613
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
A study testing Accelerated Flap Coverage Surgery in people with Open Tibia Fracture and Open Dislocation of Ankle, run by Johns Hopkins University at 31 sites in United States.
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
- 31 sitesUnited States
- Study dates
- 1 Jan 2027to Dec 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
Who may be able to join
- 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.
- Treating surgeon is willing to comply with treatment allocation.
- Able to be randomized within 72 hours of injury.
Who cannot join
- 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.
Show all 16Show fewer
- 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 (LAR) 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
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites
University of Maryland - Shock Trauma Center
Baltimore, Maryland, 21201
Mark Gage, MD, 410-448-6400, MGage@som.umaryland.edu
Johns Hopkins Hospital - Bayview Medical Center
Baltimore, Maryland, 21224
Lily Mundy, MD, 410-550-0100, lmundy3@jhu.edu
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Lily Mundy, 410-706-2492, LMundy3@jhu.edu
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Lydia Helliwell, MD, 617-732-5500, LHELLIWELL@BWH.HARVARD.EDU
University of Chicago Medicine
Chicago, Illinois, 60637
Maureen Beederman, MD, 888-824-0200, mbeederman@bsd.uchicago.edu
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Michael Beltran, MD, 513-584-1000, beltrame@ucmail.uc.edu
University of Missouri Hospital
Columbia, Missouri, 65212
Gregory Della Rocca, 573-882-4141, dellaroccag@health.missouri.edu
Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Angela Collins, 614-293-5084, angela.collins@osumc.edu
Miami Valley Hospital
Dayton, Ohio, 45409
Michael Johnson, MD, 937-208-8000, michael.johnson@wright.edu
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Abraham Goch, MD, 703-776-4001, Abraham.goch@inova.org
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Mohin Bhadkamkar, MD, 713-500-4472, Mohin.Bhadkamkar@uth.tmc.edu
IU Health University Hospital
Indianapolis, Indiana, 46202
Erin Weber, MD, 317-944-5000, eweber4@iuhealth.org
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Patrick Bergin, MD, 601-984-1000, PBergin@umc.edu
University of Maryland - Capital Region
Largo, Maryland, 20774
Mark Gage, MD, 240-677-1000, MGage@som.umaryland.edu
Keck Hospital of USC
Los Angeles, California, 90033
Joseph Patterson, MD, 800-872-2273, Joseph.Patterson@med.usc.edu
Los Angeles Medical Center
Los Angeles, California, 90033
Joseph Patterson, MD, 323-409-1000, Joseph.Patterson@med.usc.edu
Cedars-Sinai Medical Center
Los Angeles, California, 90084
Geoffrey Marecek, MD, 310-423-3277, gmarecek@gmail.com
University of Wisconsin Health University Hospital
Madison, Wisconsin, 53792
Christopher Domes, MD, 608-263-6400, domes@ortho.wisc.edu
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Elizabeth Harkin, MD, 414-955-8296, elizabeth.harkin.md@gmail.com
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lauren Tatman, MD, 615-322-5000, lauren.m.tatman@vumc.org
Yale New Haven Hospital
New Haven, Connecticut, 06510
David Colen, MD, 203-688-4242, david.colen@yale.edu
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Jessica Rivera, MD, 504-568-4808, jrive5@lsuhsc.edu
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Andrew Hollins, MD, 402-559-4000, ahollins@unmc.edu
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Michael McKee, MD, 602-839-2000, michael.mckee@bannerhealth.com
Oregon Health & Science University
Portland, Oregon, 97239
Graham DeKeyser, MD, 503-494-8311, dekeyser@ohsu.edu
Brown University Health
Providence, Rhode Island, 02903
Franca Kraenzlin, MD, 401-444-3500, FKraenzlin@brownhealth.org
UC Davis Medical Center
Sacramento, California, 95817
Ara Salibian, MD, 916-734-2011, asalibian@ucdavis.edu
University of Utah Hospital
Salt Lake City, Utah, 84132
Lucas Marchand, MD, 801-581-2121, Lucas.Marchand@hsc.utah.edu
UC San Diego Health
San Diego, California, 92121
Kathryn Dwight, MD, 858-657-8737, kddwight@health.ucsd.edu
UW Medical Center
Seattle, Washington, 98195
Jeffrey Friedrich, MD, 206-598-3300, jfriedri@uw.edu
Jamaica Hospital Medical Center
The Bronx, New York, 11418
Abhishek Ganta, MD, 718-206-6000, abhishek.ganta@nyulangone.org
About this study
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).
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
- Keywords
- flap reconstruction, flap timing, limb salvage, open fracture, open dislocation
- Medical subject headings
- Leg Injuries, Fractures, Open
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
Activation of the accelerated flap pathway with a goal flap time of <72h from injury
Standard of Care Flap TimingProcedure or surgery
Flap timing at the standard of care timing for the clinical site
| 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: 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)
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 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 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 flap complication will account for more than one operation, with the assumption that more is worse than less.
Measured: 6 and 12 months
Number of days in hospital
Days in an acute in-patient hospital (i.e., not rehab or nursing facility)
Measured: 6 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 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 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), and 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 posted18 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionDec 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
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Lily HMIR Mundy, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828613
- Sponsor's protocol ID
- IRB00525377
- Other IDs
- 1UG3AR085896
- Acronym
- FLAP ATTACK
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- 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
- NCT07828613
- Acronym / sponsor ID
- FLAP ATTACK / IRB00525377
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Keywords
- flap reconstruction, flap timing, limb salvage, open fracture, open dislocation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Sep 2026 (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).
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
Key inclusion criteria (4 listed)
- 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.
- Treating surgeon is willing to comply with treatment allocation.
- Able to be randomized within 72 hours of injury.
Key exclusion criteria (16 listed)
- 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.
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 SurgeryActivation of the accelerated flap pathway with a goal flap time of <72h from injury | Procedure or surgery | Accelerated Flap Coverage |
| Standard of Care Flap TimingFlap timing at the standard of care timing for the clinical site | 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), and 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 and 12 months
Amputation
Time frame: 6 and 12 months
Unplanned re-operation
Time frame: 6 and 12 months
Number of days in hospital
Time frame: 6 and 12 months
Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)
Time frame: 6 and 12 months
Quality of life as assessed by the Limb-Q
Time frame: 6 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 HMIR Mundy, MD principal investigator
Johns Hopkins University
31 sites in 1 country: 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 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. 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: opening soon, 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 31 sites in United States. 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.