[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"open-tibia-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:open-tibia-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100471658","phase-4-prophylactic-antibiotic-coated-nail-to-prevent-infection-a-clinical-trial-100471658",false,"NCT05421741","Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial","Inclusion Criteria:\n\n* Patients 18 years or older\n* Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Allergy to vancomycin or gentamicin\n* Unable to speak English or Spanish\n* Pregnant and lactating women\n* Prisoner\n* Unable to follow up for 12 months","ALL","18 Years",{"count":18,"type":19},484,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.",[25,26,27],"Osteomyelitis Tibia","Tibial Fractures","Open Tibia Fracture",[29],"Antibiotic-coated nail","RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":34},"2023-05-15",{"date":38,"type":19},"2027-12",{"name":40,"class":41},"Wake Forest University Health Sciences","OTHER",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100538640","accelerated-flap-coverage-in-severe-lower-extremity-trauma-100538640","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.",{"count":52,"type":19},356,[54],"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).",[27,57,58,59],"Open Dislocation of Ankle","Extremity Fracture Lower","Extremity Injuries Lower","2025-10-10",{"date":62,"type":34},"2025-10-14",{"date":64,"type":34},"2024-11-04",{"date":66,"type":19},"2030-02",{"name":68,"class":41},"Johns Hopkins University",9]