Irrisept Solution for Instrumented Spine Surgery

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.

NCT Number	NCT06439953
Lead Sponsor	Rhode Island Hospital
Conditions	Post-Op Complication, Spine Surgery, Site Infection, Surgical Site Infection, Spinal Instrumentation, Index Spinal Instrumentation, Layer-by-Layer Closure, Locoregional Flap-Based Closure
Enrollment	200 participants
Start Date	2024-10-01
Primary Completion	2028-04 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-14