Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
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.
Description
Spinal instrumentation remains the standard of care in the treatment of various traumatic, oncologic, and degenerative spinal pathologies, often requiring the implantation of hardware to stabilize the bony column. In the setting of an aging patient population and expanding indications for instrumentation in younger patients, the number of spinal operations performed has risen substantially within the past decade. Although these procedures have proven to enhance patient quality of life, spinal instrumentation is not without post-operative complication, most notable of which are surgical site in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: 18+ years old * Indications: deformity, oncologic, degenerative, trauma * Standard layer-by-layer closure * Locoregional flap-based closure Exclusion Criteria: * Acute/chronic open wounds (spine or non-spine) * On-going non-spinal infection within 30 days of index operation * Concurrent antibiotic use (for spine or non-spine infections) * History of prior spinal infection * Allergy to vancomycin or chlorhexidine * Suspicion for osteomyelitis * Other surgery within 90 days post-operatively fromm index * Concurrent enrollment in other trial
Interventions
- DeviceChlorhexidine gluconate solution
Evaluating the prophylactic use of Irrisept irrigation alone
- DrugVancomycin
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Location
- Rhode Island HospitalProvidence, Rhode Island