[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538640":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":168,"collaborators":170,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":187,"sex":193,"minAge":194,"maxAge":26,"enrollmentInfo":195,"targetDuration":26,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Accelerated Flap Coverage Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Procedure: Standard of Care Flap Timing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Accelerated Flap Coverage Surgery","Timing of the flap surgery is with a goal of 72 hours from injury",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Timing of the flap surgery is the standard of care flap timing for the participating institution.",[15],[31],{"name":32,"affiliation":33,"role":34},"Lily Mundy, MD","Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","410-706-2492","LMundy3@jhu.edu",[41,61,75,85,94,107,121,135,151],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"UC Davis Medical Center","RECRUITING","Sacramento","California","95817","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-121.4944,38.58157,{"lat":53,"lon":52},[56,58,59],{"name":57,"role":37,"phone":26,"phoneExt":26,"email":26},"Ara A Salibian, MD",{"name":57,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":60,"role":34,"phone":26,"phoneExt":26,"email":26},"Augustine M Saiz, MD",{"facility":62,"status":43,"city":63,"state":64,"zip":65,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"R Adams Cowley Shock Trauma Center","Baltimore","Maryland","21201",{"type":50,"coordinates":67},[68,69],-76.61219,39.29038,{"lat":69,"lon":68},[72,74],{"name":73,"role":37,"phone":26,"phoneExt":26,"email":26},"Mark J Gage, MD",{"name":73,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":76,"status":43,"city":63,"state":64,"zip":77,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"John Hopkins Bayview Medical Center","21224",{"type":50,"coordinates":79},[68,69],{"lat":69,"lon":68},[82,84],{"name":83,"role":37,"phone":26,"phoneExt":26,"email":26},"Lily R Mundy, MD",{"name":83,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":86,"status":43,"city":63,"state":64,"zip":87,"country":47,"countryCode":48,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"The Johns Hopkins 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University","Portland","Oregon","97239",{"type":50,"coordinates":113},[114,115],-122.67621,45.52345,{"lat":115,"lon":114},[118,120],{"name":119,"role":37,"phone":26,"phoneExt":26,"email":26},"Graham J DeKeyser, MD",{"name":119,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":122,"status":43,"city":123,"state":124,"zip":125,"country":47,"countryCode":48,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":50,"coordinates":127},[128,129],-86.78444,36.16589,{"lat":129,"lon":128},[132,134],{"name":133,"role":37,"phone":26,"phoneExt":26,"email":26},"Lauren M Tatman, MD",{"name":133,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":136,"status":43,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The Alfred Hospital","Melbourne","Victoria","3004","Australia","AU",{"type":50,"coordinates":143},[144,145],144.96332,-37.814,{"lat":145,"lon":144},[148,150],{"name":149,"role":37,"phone":26,"phoneExt":26,"email":26},"Lipi Shukla, MBBS, PhD",{"name":149,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":152,"status":43,"city":153,"state":26,"zip":154,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Vall d'Hebron University Hospital","Barcelona","08035","Spain","ES",{"type":50,"coordinates":158},[159,160],2.15899,41.38879,{"lat":160,"lon":159},[163,165,167],{"name":164,"role":37,"phone":26,"phoneExt":26,"email":26},"Jordi Tomás-Hernández, MD",{"name":166,"role":34,"phone":26,"phoneExt":26,"email":26},"Antonio Bulla, MD, PhD",{"name":164,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":169,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[171,173,175,177,179,182],{"name":172,"class":6},"McMaster University",{"name":174,"class":6},"University of Maryland, Baltimore",{"name":176,"class":6},"Orthopaedic Trauma Association",{"name":178,"class":6},"Foundation of Orthopedic Trauma",{"name":180,"class":181},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",{"name":183,"class":184},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100538640","accelerated-flap-coverage-in-severe-lower-extremity-trauma-100538640",false,"NCT06293469","Accelerated Flap Coverage in Severe Lower Extremity Trauma","Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries","FLAP ATTACK","The inclusion criteria are:\n\n1. Patients 18 years of age or older.\n2. Severe lower extremity open fracture and\u002For dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.\n3. Will have all planned flap surgeries performed by a participating surgeon or delegate.\n4. Able to be randomized within 48 hours of injury.\n\nThe exclusion criteria are:\n\n1. Site is unable to implement the accelerated flap protocol due to local logistics.\n2. Primary amputation anticipated prior to attempted flap for management of the injury.\n3. Critical limb ischemia that requires re-vascularization for limb perfusion.\n4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.\n5. Burns at the musculoskeletal injury site.\n6. Incarceration.\n7. Expected injury survival of less than 12 months.\n8. Terminal illness with expected survival of less than 12 months.\n9. Currently enrolled in a trial that does not permit co-enrollment.\n10. Declined to provide informed consent.\n11. Unable to obtain informed consent due to language barriers.\n12. Unable to obtain informed consent because a legally authorized representative was unavailable.\n13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n14. Prior enrollment in the trial.\n15. Eligible patient or LAR was not approached within screening window (missed participant).\n16. Other reason to exclude the patient, as approved by the Principal Investigators.","ALL","18 Years",{"count":196,"type":197},356,"ESTIMATED","INTERVENTIONAL",[200],"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).",[203,204,205,206],"Open Tibia Fracture","Open Dislocation of Ankle","Extremity Fracture Lower","Extremity Injuries Lower","2025-10-10",{"date":209,"type":210},"2025-10-14","ACTUAL",{"date":212,"type":210},"2024-11-04",{"date":214,"type":197},"2030-02",{"name":5,"class":6},9]