[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477854":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":25,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Balgrist University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard prophylaxis arm","ACTIVE_COMPARATOR","The standard prophylaxis consists of one to three intravenous doses of cefuroxime 1.5 g intravenously; or cefuroxim 3g if obesity \\> 120 kg or a BMI \\> 35 kg\u002Fm2; or vancomycin 1 g or clindamycin 600 mg in case of intolerance to cephalosporins\n\nIn patients alrady under current therapuetic antibiotic therapy, continuation of that therapuetic antibiotic regimen",[13],"Drug: Standard antibiotic prophylaxis",{"label":15,"type":16,"description":17,"interventionNames":18},"Innovative prophylaxis arm","EXPERIMENTAL","Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \\& gentamicin 5 mg\u002Fkg.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Standard antibiotic prophylaxis","One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"Ilker Uçkay, Professor","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","++41 44 386 37 05","ilker.uckay@balgrist.ch",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Mazda Farshad, Professor","++ 41 44 386 30 00","mazda.farshad@balgrist.ch",[40],{"facility":5,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"RECRUITING","Zurich","8008","Switzerland","CH",{"type":47,"coordinates":48},"Point",[49,50],8.55,47.36667,{"lat":50,"lon":49},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100477854","phase-3-broad-spectrum-antibiotic-prophylaxis-in-tumor-and-infected-orthopedic-surgery-100477854",false,"NCT05502380","Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery","Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials","BAPTIST","Inclusion Criteria\n\n* Age ≥ 18 years\n* Surgery under current or recent therapeutic antibiotics (antibiotic-free window \\\u003C14 days and past antibiotic prescription \\>4 days)\n* Surgery for open fractures and wounds; including 2nd and 3rd looks\n* Potentially contaminated wound revision in the operating theatre\n* Tumor (oncologic) surgery (if prior radiotherapy and\u002For bone involvement)\n* Spine surgery with ASA-Score \\>= 3 points, sacral involvement, or re-vision surgery\n* Known skin colonization with multidrug-resistant Gram-negative bacteria\n\nExclusion Criteria:\n\n* Inability to understand the study procedure for linguistic or cognitive rea-sons\n* Surgery without intraoperative microbiological samples\n* Allergy or major intolerance to vancomycin and\u002For gentamicin\n* Anticipated clinical follow-up of less than 6 weeks after inclusion\n* Pregnant or breastfeeding women\n* Known carriage of multiresistant Gram-negative bacteria in the urine or anal region","ALL","18 Years",{"count":65,"type":66},1100,"ESTIMATED","INTERVENTIONAL",[69],"PHASE3","The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases).\n\nHowever, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on \"selection\" by antibiotics used for therapy or for prophylaxis.",[72,73,74],"Surgical Site Infection","Microbial Colonization","Antibiotic Resistant Infection",[76,77,78,79],"Perioperative antibiotic prophylaxis","Selection","High Risk patients","Ranndomized-Controlled Trial","2024-11-28",{"date":82,"type":83},"2024-12-02","ACTUAL",{"date":85,"type":83},"2022-09-15",{"date":87,"type":66},"2025-12-12",{"name":5,"class":6},1]