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Irrisept Solution for Instrumented Spine Surgery
Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Chlorhexidine gluconate solution (device)
- Vancomycin (drug)
Sponsor: Rhode Island Hospital · Participants: 200 · Started: Oct 1, 2024
Contact the study team
- Alexander Chernysh · Phone: 401-444-9868
- Owen Leary · Phone: 401-6068388
Official record on ClinicalTrials.gov — NCT06439953
Locations in the U.S.
| Rhode Island | Rhode Island Hospital, Providence |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.