[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100123147":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":41,"responsibleParty":64,"collaborators":67,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":23,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":44,"whyStopped":23,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Formal Operative Treatment","Children randomized to the formal operative management arm will be taken to the Operating Room within 24 hours for irrigation and debridement and appropriate bone management.",[12],"Procedure: Formal Operative Treatment",{"label":14,"type":6,"description":15,"interventionNames":16},"Emergency Department Treatment","Children in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.",[17],"Procedure: Emergency Department Treatment",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.",[14],[28],{"name":29,"affiliation":5,"role":30},"Joseph (Jay) A Janicki, MD, MS","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":23,"email":36},"Jamie K Burgess, PhD, CCRP","CONTACT","312-227-6531","jburgess@luriechildrens.org",{"name":38,"role":34,"phone":39,"phoneExt":23,"email":40},"Michelle S Adzido, MA","312-227-2492","madzido@luriechildrens.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Ann & Robert H. Lurie Children's Hospital of Chicago","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-87.65005,41.85003,{"lat":54,"lon":53},[57,60],{"name":29,"role":34,"phone":58,"phoneExt":23,"email":59},"312-227-6194","jjanicki@luriechildrens.org",{"name":61,"role":34,"phone":62,"phoneExt":23,"email":63},"Carly A Strohbach, BA","312-227-6627","cstrohbach@luriechildrens.org",{"type":30,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Joseph Janicki","MD, Assistant Professor of Pediatrics, Northwestern University Feinberg School of Medicine",[68,70,72,74,76,79,81,83,85,87,89,91,93,95,97,99,101],{"name":69,"class":6},"Provincial Health Services Authority British Columbia",{"name":71,"class":6},"University of Mississippi Medical Center",{"name":73,"class":6},"MultiCare Mary Bridge Children's Hospital & Health Center",{"name":75,"class":6},"Yale New Haven Health System Center for Healthcare Solutions",{"name":77,"class":78},"University of New Mexico Carrie Tingley Hospital","UNKNOWN",{"name":80,"class":6},"IWK Health Centre",{"name":82,"class":6},"Phoenix Children's Hospital",{"name":84,"class":6},"Children's Hospital Colorado",{"name":86,"class":6},"Nationwide Children's Hospital",{"name":88,"class":6},"Morristown Medical Center",{"name":90,"class":78},"NYUMC-Hospital for Joint Diseases",{"name":92,"class":6},"Children's Medical Center Dallas",{"name":94,"class":6},"Johns Hopkins University",{"name":96,"class":6},"Orthopaedic Institute for Children",{"name":98,"class":6},"Children's Hospital Los Angeles",{"name":100,"class":6},"St. Christopher's Hospital for Children",{"name":102,"class":6},"Children's Hospital of Orange County","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":115,"type":116},300,"ESTIMATED","INTERVENTIONAL",[119],"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.",[122],"Fractures, Open",[124,122,125],"Surgical Procedures, Operative","Fracture Fixation","2026-06-30",{"date":128,"type":129},"2026-07-01","ACTUAL",{"date":131,"type":129},"2010-03",{"date":133,"type":116},"2027-09",{"name":5,"class":6},1]