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Irrisept Solution for Instrumented Spine Surgery
Sponsor: Rhode Island Hospital
Summary
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.
Official title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-10-01
Completion Date
2026-09-30
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
Chlorhexidine gluconate solution
Evaluating the prophylactic use of Irrisept irrigation alone
Vancomycin
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Locations (1)
Rhode Island Hospital
Providence, Rhode Island, United States