[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-instrumentation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-instrumentation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33],"Post-Op Complication","Spine Surgery","Site Infection","Surgical Site Infection","Spinal Instrumentation","Index Spinal Instrumentation","Layer-by-Layer Closure","Locoregional Flap-Based Closure","RECRUITING","2024-11-18",{"date":37,"type":38},"2024-11-20","ACTUAL",{"date":40,"type":38},"2024-10-01",{"date":42,"type":20},"2026-09-30",{"name":44,"class":45},"Rhode Island Hospital","OTHER"]