[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344507":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":79,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":18,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.",[13],"Drug: Vancomycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Observational Arm","Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Vancomycin","2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.",[9],[29,30,31],"NDC (National Drug Code) 67457-340-01","Topical vancomycin","Vancomycin powder",[33],{"name":34,"affiliation":35,"role":36},"Robert A De Lorenzo, MD","University of Texas","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":18,"email":41},"CONTACT","210-567-0056","DeLorenzo@uthscsa.edu",[43,67],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-98.49363,29.42412,{"lat":55,"lon":54},[58,62,66],{"name":59,"role":39,"phone":60,"phoneExt":18,"email":61},"Robert DeLorenzo, MD","210-567-4292","delorenzo@uthscsa.edu",{"name":63,"role":39,"phone":64,"phoneExt":18,"email":65},"Stephanie Martinez","210 450-8566","martinezs13@uthscsa.edu",{"name":34,"role":36,"phone":18,"phoneExt":18,"email":18},{"facility":68,"status":69,"city":46,"state":47,"zip":70,"country":49,"countryCode":50,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"San Antonio Military Medical Center","NOT_YET_RECRUITING","78234",{"type":52,"coordinates":72},[54,55],{"lat":55,"lon":54},[75,78],{"name":76,"role":39,"phone":18,"phoneExt":18,"email":77},"Steven G Schauer, DO","steven.g.schauer.mil@mail.mil",{"name":76,"role":36,"phone":18,"phoneExt":18,"email":18},{"type":80,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[82,85],{"name":83,"class":84},"United States Army Institute of Surgical Research","FED",{"name":68,"class":84},"100344507","phase-4-placement-of-antibiotic-powder-in-wounds-during-the-emergency-room-100344507",false,"NCT03765567","Placement of Antibiotic Powder in Wounds During the Emergency Room","Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study","POWDER","Inclusion Criteria:\n\n* Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.\n* Adult 18 years of age or older.\n* Open fracture of the humerus, radius, ulna, femur, tibia, and\u002For fibula.\n* 24 hours or less has elapsed from the estimated time of injury to study intervention.\n\nExclusion Criteria:\n\n* Time from injury \\> 24 hours.\n* Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.\n* Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).\n* High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.\n* Documented allergies or serious reactions to vancomycin. History of uncomplicated \"red man syndrome\" will not be considered a reason for exclusion.\n* Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.\n* Prisoners.\n* Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.","ALL","18 Years","89 Years",{"count":98,"type":99},200,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.",[105],"Open Fracture",[107,108,109,110],"infection","vancomycin","topical antibiotic","antibiotic prophylaxis","2025-07-30",{"date":113,"type":114},"2025-08-01","ACTUAL",{"date":116,"type":114},"2020-10-05",{"date":118,"type":99},"2027-07",{"name":5,"class":6},2]