[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fractures-open\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fractures-open":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100123147","the-treatment-of-type-i-open-fractures-in-pediatrics-100123147",false,"NCT00870064","The Treatment of Type I Open Fractures in Pediatrics","The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement","PROOF","Inclusion Criteria:\n\n* open fracture amenable to treatment by closed reduction\n* low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)\n* wound less than 1cm in length and the bone not visualized through the skin\n\nExclusion Criteria:\n\n* open fracture not amenable to treatment by closed reduction\n* open fracture that would typically require operative reduction and fixation\n* high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)\n* wound greater than 1cm in length\n* gross contamination of wound\n* open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)","ALL","3 Years","14 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.",[28],"Fractures, Open",[30,28,31],"Surgical Procedures, Operative","Fracture Fixation","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2010-03",{"date":40,"type":22},"2027-09",{"name":42,"class":43},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100385462","safety-efficacy--use-of-vivigen-cellular-bone-matrix-allograft-in-orthopaedic-fracture-care-100385462","NCT04299022","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study","Prospective Cohort Inclusion Criteria:\n\n* Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.\n\nRetrospective Cohort Inclusion Criteria:\n\n\\- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.\n\nProspective Cohort Exclusion Criteria:\n\n1. Patients unable to understand either an English or Spanish consent will be excluded.\n2. Patients unable to consent secondary to dementia and\u002For other mental\u002Fpsychiatric diagnoses will be excluded.",{"count":53,"type":22},250,"24 Months","OBSERVATIONAL","Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.",[58,59,28,60,61,62,63],"Fractures, Bone","Nonunion of Fracture","Fractures, Ununited","Fracture, Tibial","Fracture of Femur","Fracture Arm",[65,66,67],"fracture","nonunion","allograft","2025-03-28",{"date":70,"type":36},"2025-04-02",{"date":72,"type":36},"2021-06-01",{"date":74,"type":22},"2026-07-31",{"name":76,"class":77},"LifeNet Health","INDUSTRY",4,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":44},"100554892","phase-4-powdered-intrawound-vancomycin-in-open-fractures-trial-100554892","NCT06504992","Powdered Intrawound Vancomycin in Open Fractures Trial","Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial","PIVOT","Inclusion Criteria:\n\n* 18 years or older at time of surgery\n* Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).\n* Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).\n* Able to attend standard of care follow up for six months post-operatively\n\nExclusion Criteria:\n\n* Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin.\n* Patients who have already had definitive fracture fixation before enrollment in the study\n* Patients with open fracture already infected at time of enrollment\n* Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).\n* Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)\n* Patients who do not speak English\n* Patients who are currently pregnant\n* Patients who are unable to provide consent and do not have a substitute decision maker able to provide consent\n* Patients who will have severe difficulty with follow up","18 Years",{"count":89,"type":22},350,[91],"PHASE4","The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.",[94,95,96,28,97,58,98],"Open Fracture","Trauma","Infection, Surgical Site","Wound Infection","Post-Operative Wound Infection",[100,101,102,103,104],"open fracture","vancomycin","infection","trauma","intrawound","NOT_YET_RECRUITING","2024-09-17",{"date":108,"type":36},"2024-09-19",{"date":110,"type":22},"2024-11-01",{"date":112,"type":22},"2029-09-01",{"name":114,"class":43},"University of Manitoba"]