[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512988":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":57,"collaborators":12,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":12,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":44,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Rabin Medical Center","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","2 g of IV cefazolin will be administered within 60 minutes before surgical incision (3 g for pts weighing ≥120 kg), repeated dose in the operating room every four hours (allergic patients will receive 900 mg of clindamycin within 60 minutes which will be repeated every six hours or 15 mg\u002Fkg of vancomycin once within two hours before incision).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention group: 500 mg vancomycin","EXPERIMENTAL","Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis",[18],"Drug: Vancomycin",{"label":20,"type":15,"description":21,"interventionNames":22},"Intervention group: 1 g vancomycin","Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DRUG","Vancomycin","Powdered vancomycin will be locally administered once during surgery. The vancomycin will be placed in the surgical bed at several layers: around the hardware and before muscle apposition and above the fascia. This is done before the closure of the muscular fascia and skin by the neurosurgeon. The vancomycin will not be mixed in the bone graft.",[20,14],[30],{"name":31,"affiliation":5,"role":32},"Eyal Itshayek, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":12,"email":37},"CONTACT","+972-50-8946921","eyal.itshayek@gmail.com",{"name":39,"role":35,"phone":40,"phoneExt":12,"email":41},"Shani Berkowitz, Msc","+972528620737","shanihberkowitz@gmail.com",[43],{"facility":5,"status":44,"city":45,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Petah Tikva","Israel","IL",{"type":49,"coordinates":50},"Point",[51,52],34.88747,32.08707,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":12,"phoneExt":12,"email":12},"Belaynesh Keren Melke, BSc",{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Eyal Itshayek","Prof. Eyal Itshayek","100512988","phase-3-intra-wound-vancomycin-powder-for-prevention-of-surgical-site-infection-following-spinal-surgery-100512988",false,"NCT05959603","Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery","Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n* Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center\n* Ability to understand and sign written informed consent by the patient or legal guardian\n\nExclusion Criteria:\n\n* Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)\n* Receiving ongoing treatment of antibiotics for other infections\n* Sensitivity or allergy to vancomycin or cefazolin\n* Previous spine surgery at the index level within the last 90 days\n* Postoperative radiotherapy of the surgical site required (e.g. for tumor)\n* Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml\u002Fmin or worse\n* Undergoing spinal decompression only\n* Trauma patients\n* Pregnancy","ALL","18 Years","90 Years",{"count":71,"type":72},363,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.",[78],"Infection",[26,80,81],"Infections","Surgical Site","2024-11-24",{"date":84,"type":85},"2024-11-27","ACTUAL",{"date":87,"type":85},"2020-05-31",{"date":89,"type":72},"2026-12-01",{"name":5,"class":6},1]