Actively Recruiting
Irrisept Solution for Instrumented Spine Surgery
Led by Rhode Island Hospital · Updated on 2024-11-20
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Irrisept Solution for Instrumented Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age: 18+ years old
- Undergoing spinal instrumentation surgery for deformity, cancer, degenerative disease, or trauma
- Standard layer-by-layer wound closure
- Locoregional flap-based wound closure
You will not qualify if you...
- Presence of acute or chronic open wounds anywhere on the body
- Active infection (not spinal) within 30 days before surgery
- Current antibiotic use for any infection
- History of prior spinal infection
- Allergy to vancomycin or chlorhexidine
- Suspicion of bone infection (osteomyelitis)
- Any surgery within 90 days after the spinal surgery
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
A
Alexander Chernysh
CONTACT
O
Owen Leary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here