[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549891":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":41,"locations":52,"responsibleParty":71,"collaborators":46,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":46,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":46,"enrollmentInfo":82,"targetDuration":46,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":46,"overallStatus":54,"whyStopped":46,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Irrisept Irrigation","EXPERIMENTAL","Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.",[13],"Device: Chlorhexidine gluconate solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Vancomycin-saline Irrigation","ACTIVE_COMPARATOR","Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.",[19],"Drug: Vancomycin",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Chlorhexidine gluconate solution","Evaluating the prophylactic use of Irrisept irrigation alone",[9],[27],"Irrisept irrigation",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Vancomycin","Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin",[15],[34],"Vancomycin-saline",[36,39],{"name":37,"affiliation":5,"role":38},"Jared S. Fridley, MD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Albert S. Woo, MD",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Alexander Chernysh","CONTACT","401-444-9868",null,"AChernysh@lifespan.org",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Owen Leary","401-6068388","owen.leary@lifespan.org",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-71.41283,41.82399,{"lat":64,"lon":63},[67,69,70],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":68},"AChernysh@Lifespan.org",{"name":37,"role":44,"phone":46,"phoneExt":46,"email":46},{"name":40,"role":44,"phone":46,"phoneExt":46,"email":46},{"type":72,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100549891","irrisept-solution-for-instrumented-spine-surgery-100549891",false,"NCT06439953","Irrisept Solution for Instrumented Spine Surgery","Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation","Inclusion Criteria:\n\n* Age: 18+ years old\n* Indications: deformity, oncologic, degenerative, trauma\n* Standard layer-by-layer closure\n* Locoregional flap-based closure\n\nExclusion Criteria:\n\n* Acute\u002Fchronic open wounds (spine or non-spine)\n* On-going non-spinal infection within 30 days of index operation\n* Concurrent antibiotic use (for spine or non-spine infections)\n* History of prior spinal infection\n* Allergy to vancomycin or chlorhexidine\n* Suspicion for osteomyelitis\n* Other surgery within 90 days post-operatively fromm index\n* Concurrent enrollment in other trial","ALL","18 Years",{"count":83,"type":84},200,"ESTIMATED","INTERVENTIONAL",[87],"NA","Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.",[90,91,92,93,94,95,96,97],"Post-Op Complication","Spine Surgery","Site Infection","Surgical Site Infection","Spinal Instrumentation","Index Spinal Instrumentation","Layer-by-Layer Closure","Locoregional Flap-Based Closure","2024-11-18",{"date":100,"type":101},"2024-11-20","ACTUAL",{"date":103,"type":101},"2024-10-01",{"date":105,"type":84},"2026-09-30",{"name":5,"class":6},1]