[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656549":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":56,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":515,"collaborators":517,"id":521,"slug":522,"hasResults":523,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":523,"sex":528,"minAge":529,"maxAge":35,"enrollmentInfo":530,"targetDuration":35,"studyType":533,"phases":534,"briefSummary":536,"conditions":537,"keywords":542,"overallStatus":548,"whyStopped":35,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":558},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002For flap complication (flap compromise, partial and\u002For complete flap failure), and 4) Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)","6 months",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Mortality","All-cause mortality. Mortality will be time-to-event, with the assumption that earlier is worse than later.","6 and 12 months",{"measure":19,"description":20,"timeFrame":17},"Amputation","Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later.",{"measure":22,"description":23,"timeFrame":17},"Unplanned re-operation","Unplanned re-operation for infection and\u002For flap complication (flap compromise, partial and\u002For 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.",{"measure":25,"description":26,"timeFrame":17},"Number of days in hospital","Days in an acute in-patient hospital (i.e., not rehab or nursing facility)",{"measure":28,"description":29,"timeFrame":17},"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.\"",{"measure":31,"description":32,"timeFrame":17},"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.",{"measure":10,"description":11,"timeFrame":34},"12 months",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","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.\n\nThe 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\u002For 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.\n\nThe 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\u002For flap complication (flap compromise, partial and\u002For 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.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"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.",[49],"Procedure: Accelerated Flap Coverage Surgery",{"label":51,"type":52,"description":53,"interventionNames":54},"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.",[55],"Procedure: Standard of Care Flap Timing",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":35},"PROCEDURE","Accelerated Flap Coverage Surgery","Activation of the accelerated flap pathway with a goal flap time of \\\u003C72h from injury",[45],{"type":58,"name":51,"description":63,"armGroupLabels":64,"otherNames":35},"Flap timing at the standard of care timing for the clinical site",[51],[66],{"name":67,"affiliation":5,"role":68},"Lily HMIR Mundy, MD","PRINCIPAL_INVESTIGATOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":35,"email":74},"Lily Mundy, MD","CONTACT","(410)706-2492","lmundy3@jhu.edu",[76,94,109,117,128,142,156,171,186,201,216,231,240,251,263,278,293,308,323,338,353,367,381,396,411,426,441,456,471,486,501],{"facility":77,"status":35,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Banner - University Medical Center Phoenix","Phoenix","Arizona","85006","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-112.07404,33.44838,{"lat":87,"lon":86},[90],{"name":91,"role":72,"phone":92,"phoneExt":35,"email":93},"Michael McKee, MD","602-839-2000","michael.mckee@bannerhealth.com",{"facility":95,"status":35,"city":96,"state":97,"zip":98,"country":81,"countryCode":82,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Keck Hospital of USC","Los Angeles","California","90033",{"type":84,"coordinates":100},[101,102],-118.24368,34.05223,{"lat":102,"lon":101},[105],{"name":106,"role":72,"phone":107,"phoneExt":35,"email":108},"Joseph Patterson, MD","800-872-2273","Joseph.Patterson@med.usc.edu",{"facility":110,"status":35,"city":96,"state":97,"zip":98,"country":81,"countryCode":82,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Los Angeles Medical Center",{"type":84,"coordinates":112},[101,102],{"lat":102,"lon":101},[115],{"name":106,"role":72,"phone":116,"phoneExt":35,"email":108},"323-409-1000",{"facility":118,"status":35,"city":96,"state":97,"zip":119,"country":81,"countryCode":82,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Cedars-Sinai Medical Center","90084",{"type":84,"coordinates":121},[101,102],{"lat":102,"lon":101},[124],{"name":125,"role":72,"phone":126,"phoneExt":35,"email":127},"Geoffrey Marecek, MD","310-423-3277","gmarecek@gmail.com",{"facility":129,"status":35,"city":130,"state":97,"zip":131,"country":81,"countryCode":82,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"UC Davis Medical Center","Sacramento","95817",{"type":84,"coordinates":133},[134,135],-121.4944,38.58157,{"lat":135,"lon":134},[138],{"name":139,"role":72,"phone":140,"phoneExt":35,"email":141},"Ara Salibian, MD","916-734-2011","asalibian@ucdavis.edu",{"facility":143,"status":35,"city":144,"state":97,"zip":145,"country":81,"countryCode":82,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"UC San Diego Health","San Diego","92121",{"type":84,"coordinates":147},[148,149],-117.16472,32.71571,{"lat":149,"lon":148},[152],{"name":153,"role":72,"phone":154,"phoneExt":35,"email":155},"Kathryn Dwight, MD","858-657-8737","kddwight@health.ucsd.edu",{"facility":157,"status":35,"city":158,"state":159,"zip":160,"country":81,"countryCode":82,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Yale New Haven Hospital","New Haven","Connecticut","06510",{"type":84,"coordinates":162},[163,164],-72.92816,41.30815,{"lat":164,"lon":163},[167],{"name":168,"role":72,"phone":169,"phoneExt":35,"email":170},"David Colen, MD","203-688-4242","david.colen@yale.edu",{"facility":172,"status":35,"city":173,"state":174,"zip":175,"country":81,"countryCode":82,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"University of Chicago Medicine","Chicago","Illinois","60637",{"type":84,"coordinates":177},[178,179],-87.65005,41.85003,{"lat":179,"lon":178},[182],{"name":183,"role":72,"phone":184,"phoneExt":35,"email":185},"Maureen Beederman, MD","888-824-0200","mbeederman@bsd.uchicago.edu",{"facility":187,"status":35,"city":188,"state":189,"zip":190,"country":81,"countryCode":82,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"IU Health University Hospital","Indianapolis","Indiana","46202",{"type":84,"coordinates":192},[193,194],-86.15804,39.76838,{"lat":194,"lon":193},[197],{"name":198,"role":72,"phone":199,"phoneExt":35,"email":200},"Erin Weber, MD","317-944-5000","eweber4@iuhealth.org",{"facility":202,"status":35,"city":203,"state":204,"zip":205,"country":81,"countryCode":82,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Louisiana State University Health Sciences Center","New Orleans","Louisiana","70112",{"type":84,"coordinates":207},[208,209],-90.07507,29.95465,{"lat":209,"lon":208},[212],{"name":213,"role":72,"phone":214,"phoneExt":35,"email":215},"Jessica Rivera, MD","504-568-4808","jrive5@lsuhsc.edu",{"facility":217,"status":35,"city":218,"state":219,"zip":220,"country":81,"countryCode":82,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"University of Maryland - Shock Trauma Center","Baltimore","Maryland","21201",{"type":84,"coordinates":222},[223,224],-76.61219,39.29038,{"lat":224,"lon":223},[227],{"name":228,"role":72,"phone":229,"phoneExt":35,"email":230},"Mark Gage, MD","410-448-6400","MGage@som.umaryland.edu",{"facility":232,"status":35,"city":218,"state":219,"zip":233,"country":81,"countryCode":82,"cosmosGeoPoint":234,"geoPoint":236,"contacts":237},"Johns Hopkins Hospital - Bayview Medical Center","21224",{"type":84,"coordinates":235},[223,224],{"lat":224,"lon":223},[238],{"name":71,"role":72,"phone":239,"phoneExt":35,"email":74},"410-550-0100",{"facility":241,"status":35,"city":218,"state":219,"zip":242,"country":81,"countryCode":82,"cosmosGeoPoint":243,"geoPoint":245,"contacts":246},"Johns Hopkins Hospital","21287",{"type":84,"coordinates":244},[223,224],{"lat":224,"lon":223},[247],{"name":248,"role":72,"phone":249,"phoneExt":35,"email":250},"Lily Mundy","410-706-2492","LMundy3@jhu.edu",{"facility":252,"status":35,"city":253,"state":219,"zip":254,"country":81,"countryCode":82,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"University of Maryland - Capital Region","Largo","20774",{"type":84,"coordinates":256},[257,258],-76.83025,38.89761,{"lat":258,"lon":257},[261],{"name":228,"role":72,"phone":262,"phoneExt":35,"email":230},"240-677-1000",{"facility":264,"status":35,"city":265,"state":266,"zip":267,"country":81,"countryCode":82,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"type":84,"coordinates":269},[270,271],-71.05977,42.35843,{"lat":271,"lon":270},[274],{"name":275,"role":72,"phone":276,"phoneExt":35,"email":277},"Lydia Helliwell, MD","617-732-5500","LHELLIWELL@BWH.HARVARD.EDU",{"facility":279,"status":35,"city":280,"state":281,"zip":282,"country":81,"countryCode":82,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":84,"coordinates":284},[285,286],-90.18481,32.29876,{"lat":286,"lon":285},[289],{"name":290,"role":72,"phone":291,"phoneExt":35,"email":292},"Patrick Bergin, MD","601-984-1000","PBergin@umc.edu",{"facility":294,"status":35,"city":295,"state":296,"zip":297,"country":81,"countryCode":82,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"University of Missouri Hospital","Columbia","Missouri","65212",{"type":84,"coordinates":299},[300,301],-92.33407,38.95171,{"lat":301,"lon":300},[304],{"name":305,"role":72,"phone":306,"phoneExt":35,"email":307},"Gregory Della Rocca","573-882-4141","dellaroccag@health.missouri.edu",{"facility":309,"status":35,"city":310,"state":311,"zip":312,"country":81,"countryCode":82,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"University of Nebraska Medical Center","Omaha","Nebraska","68198",{"type":84,"coordinates":314},[315,316],-95.94043,41.25626,{"lat":316,"lon":315},[319],{"name":320,"role":72,"phone":321,"phoneExt":35,"email":322},"Andrew Hollins, MD","402-559-4000","ahollins@unmc.edu",{"facility":324,"status":35,"city":325,"state":326,"zip":327,"country":81,"countryCode":82,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Jamaica Hospital Medical Center","The Bronx","New York","11418",{"type":84,"coordinates":329},[330,331],-73.86641,40.84985,{"lat":331,"lon":330},[334],{"name":335,"role":72,"phone":336,"phoneExt":35,"email":337},"Abhishek Ganta, MD","718-206-6000","abhishek.ganta@nyulangone.org",{"facility":339,"status":35,"city":340,"state":341,"zip":342,"country":81,"countryCode":82,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"University of Cincinnati Medical Center","Cincinnati","Ohio","45219",{"type":84,"coordinates":344},[345,346],-84.51439,39.12711,{"lat":346,"lon":345},[349],{"name":350,"role":72,"phone":351,"phoneExt":35,"email":352},"Michael Beltran, MD","513-584-1000","beltrame@ucmail.uc.edu",{"facility":354,"status":35,"city":355,"state":341,"zip":356,"country":81,"countryCode":82,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Ohio State University Wexner Medical Center","Columbus","43221",{"type":84,"coordinates":358},[359,360],-82.99879,39.96118,{"lat":360,"lon":359},[363],{"name":364,"role":72,"phone":365,"phoneExt":35,"email":366},"Angela Collins","614-293-5084","angela.collins@osumc.edu",{"facility":368,"status":35,"city":369,"state":341,"zip":370,"country":81,"countryCode":82,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Miami Valley Hospital","Dayton","45409",{"type":84,"coordinates":372},[373,374],-84.19161,39.75895,{"lat":374,"lon":373},[377],{"name":378,"role":72,"phone":379,"phoneExt":35,"email":380},"Michael Johnson, MD","937-208-8000","michael.johnson@wright.edu",{"facility":382,"status":35,"city":383,"state":384,"zip":385,"country":81,"countryCode":82,"cosmosGeoPoint":386,"geoPoint":390,"contacts":391},"Oregon Health & Science University","Portland","Oregon","97239",{"type":84,"coordinates":387},[388,389],-122.67621,45.52345,{"lat":389,"lon":388},[392],{"name":393,"role":72,"phone":394,"phoneExt":35,"email":395},"Graham DeKeyser, MD","503-494-8311","dekeyser@ohsu.edu",{"facility":397,"status":35,"city":398,"state":399,"zip":400,"country":81,"countryCode":82,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"Brown University Health","Providence","Rhode Island","02903",{"type":84,"coordinates":402},[403,404],-71.41283,41.82399,{"lat":404,"lon":403},[407],{"name":408,"role":72,"phone":409,"phoneExt":35,"email":410},"Franca Kraenzlin, MD","401-444-3500","FKraenzlin@brownhealth.org",{"facility":412,"status":35,"city":413,"state":414,"zip":415,"country":81,"countryCode":82,"cosmosGeoPoint":416,"geoPoint":420,"contacts":421},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":84,"coordinates":417},[418,419],-86.78444,36.16589,{"lat":419,"lon":418},[422],{"name":423,"role":72,"phone":424,"phoneExt":35,"email":425},"Lauren Tatman, MD","615-322-5000","lauren.m.tatman@vumc.org",{"facility":427,"status":35,"city":428,"state":429,"zip":430,"country":81,"countryCode":82,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"The University of Texas Health Science Center at Houston","Houston","Texas","77030",{"type":84,"coordinates":432},[433,434],-95.36327,29.76328,{"lat":434,"lon":433},[437],{"name":438,"role":72,"phone":439,"phoneExt":35,"email":440},"Mohin Bhadkamkar, MD","713-500-4472","Mohin.Bhadkamkar@uth.tmc.edu",{"facility":442,"status":35,"city":443,"state":444,"zip":445,"country":81,"countryCode":82,"cosmosGeoPoint":446,"geoPoint":450,"contacts":451},"University of Utah Hospital","Salt Lake City","Utah","84132",{"type":84,"coordinates":447},[448,449],-111.89105,40.76078,{"lat":449,"lon":448},[452],{"name":453,"role":72,"phone":454,"phoneExt":35,"email":455},"Lucas Marchand, MD","801-581-2121","Lucas.Marchand@hsc.utah.edu",{"facility":457,"status":35,"city":458,"state":459,"zip":460,"country":81,"countryCode":82,"cosmosGeoPoint":461,"geoPoint":465,"contacts":466},"Inova Fairfax Hospital","Falls Church","Virginia","22042",{"type":84,"coordinates":462},[463,464],-77.17109,38.88233,{"lat":464,"lon":463},[467],{"name":468,"role":72,"phone":469,"phoneExt":35,"email":470},"Abraham Goch, MD","703-776-4001","Abraham.goch@inova.org",{"facility":472,"status":35,"city":473,"state":474,"zip":475,"country":81,"countryCode":82,"cosmosGeoPoint":476,"geoPoint":480,"contacts":481},"UW Medical Center","Seattle","Washington","98195",{"type":84,"coordinates":477},[478,479],-122.33207,47.60621,{"lat":479,"lon":478},[482],{"name":483,"role":72,"phone":484,"phoneExt":35,"email":485},"Jeffrey Friedrich, MD","206-598-3300","jfriedri@uw.edu",{"facility":487,"status":35,"city":488,"state":489,"zip":490,"country":81,"countryCode":82,"cosmosGeoPoint":491,"geoPoint":495,"contacts":496},"University of Wisconsin Health University Hospital","Madison","Wisconsin","53792",{"type":84,"coordinates":492},[493,494],-89.40123,43.07305,{"lat":494,"lon":493},[497],{"name":498,"role":72,"phone":499,"phoneExt":35,"email":500},"Christopher Domes, MD","608-263-6400","domes@ortho.wisc.edu",{"facility":502,"status":35,"city":503,"state":489,"zip":504,"country":81,"countryCode":82,"cosmosGeoPoint":505,"geoPoint":509,"contacts":510},"Medical College of Wisconsin","Milwaukee","53226",{"type":84,"coordinates":506},[507,508],-87.90647,43.0389,{"lat":508,"lon":507},[511],{"name":512,"role":72,"phone":513,"phoneExt":35,"email":514},"Elizabeth Harkin, MD","414-955-8296","elizabeth.harkin.md@gmail.com",{"type":516,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[518],{"name":519,"class":520},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH","100656549","accelerated-flap-coverage-versus-standard-timing-in-the-treatment-of-severe-lower-extremity-musculoskeletal-injuries-100656549",false,"NCT07828613","Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries","FLAP ATTACK","Inclusion Criteria:\n\n* Patients 18 years of age or older.\n* Severe lower extremity open fracture and\u002For dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.\n* Treating surgeon is willing to comply with treatment allocation.\n* Able to be randomized within 72 hours of injury.\n\nExclusion Criteria:\n\n* Site is unable to implement the accelerated flap protocol due to local logistics.\n* Primary amputation anticipated prior to attempted flap for management of the injury.\n* Critical limb ischemia that requires re-vascularization for limb perfusion.\n* Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.\n* Burns at the musculoskeletal injury site.\n* Incarceration.\n* Expected injury survival of less than 12 months.\n* Terminal illness with expected survival of less than 12 months.\n* Currently enrolled in a trial that does not permit co-enrollment.\n* Declined to provide informed consent.\n* Unable to obtain informed consent due to language barriers.\n* Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.\n* Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n* Prior enrollment in the trial.\n* Eligible patient or LAR was not approached within screening window (missed participant).\n* Other reason to exclude the patient, as approved by the Principal Investigators.","ALL","18 Years",{"count":531,"type":532},356,"ESTIMATED","INTERVENTIONAL",[535],"NA","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\u002For 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\u002For flap complication (flap compromise, partial and\u002For complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).",[538,539,540,541],"Open Tibia Fracture","Open Dislocation of Ankle","Extremity Fracture Lower","Extremity Injuries Lower",[543,544,545,546,547],"flap reconstruction","flap timing","limb salvage","open fracture","open dislocation","NOT_YET_RECRUITING","2026-09-15",{"date":551,"type":552},"2026-09-18","ACTUAL",{"date":554,"type":532},"2027-01-01",{"date":556,"type":532},"2030-12",{"name":5,"class":6},31]