Irrisept Solution for Instrumented Spine Surgery
Recruiting
N/A
Interventional Study
Post-Op Complication
Spine Surgery
Site Infection
Surgical Site Infection
Spinal Instrumentation
Index Spinal Instrumentation
Layer-by-Layer Closure
Locoregional Flap-Based Closure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 200 (estimated)
- Sponsor
- Rhode Island Hospital · Other
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About This Trial
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 bed…
Trial Locations
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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 opera…
Contacts