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