Irrisept Solution for Instrumented Spine Surgery
Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Rhode Island Hospital
200 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Age: 18+ years old
- Indications: deformity, oncologic, degenerative, trauma
- Standard layer-by-layer closure
- Locoregional flap-based closure
Exclusion Criteria8
- 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
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Interventions
Evaluating the prophylactic use of Irrisept irrigation alone
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Locations(1)
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NCT06439953