[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554892":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":38,"responsibleParty":52,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":83,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Manitoba","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement",[13],"Drug: Vancomycin 1000 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Intravenous antibiotics with irrigation and debridement alone.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Vancomycin 1000 MG",[9],[9],[26,29],{"name":27,"affiliation":5,"role":28},"Gabriel Larose, MD, MSc, FRCSC","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Madison Price, MD",[32,36],{"name":27,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","2047872261","glarose@hsc.mb.ca",{"name":30,"role":33,"phone":18,"phoneExt":18,"email":37},"pricem@myumanitoba.ca",[39],{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Health Sciences Centre Winnipeg","Winnipeg","Manitoba","R3A 1R9","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-97.14704,49.8844,{"lat":50,"lon":49},{"type":28,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Madison Price","Doctor of Medicine, PI under Dr. Gabriel Larose",[56],{"name":57,"class":6},"Health Sciences Centre, Winnipeg, Manitoba","100554892","phase-4-powdered-intrawound-vancomycin-in-open-fractures-trial-100554892",false,"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","ALL","18 Years",{"count":69,"type":70},350,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76,77,78,79,80,81,82],"Open Fracture","Trauma","Infection, Surgical Site","Fractures, Open","Wound Infection","Fractures, Bone","Post-Operative Wound Infection",[84,85,86,87,88],"open fracture","vancomycin","infection","trauma","intrawound","NOT_YET_RECRUITING","2024-09-17",{"date":92,"type":93},"2024-09-19","ACTUAL",{"date":95,"type":70},"2024-11-01",{"date":97,"type":70},"2029-09-01",{"name":5,"class":6},1]