NCT06439953 Irrisept Solution for Instrumented Spine Surgery
| NCT ID | NCT06439953 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Post-Op Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jared S. Fridley, MD
PRINCIPAL INVESTIGATOR
Rhode Island Hospital
Frequently Asked Questions
Who can join the NCT06439953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Op Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06439953 currently recruiting?
Yes, NCT06439953 is actively recruiting participants. Contact the research team at AChernysh@lifespan.org for enrollment information.
Where is the NCT06439953 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06439953 clinical trial?
NCT06439953 is sponsored by Rhode Island Hospital. The principal investigator is Jared S. Fridley, MD at Rhode Island Hospital. The trial plans to enroll 200 participants.