Irrisept Solution for Instrumented Spine Surgery

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT06439953
Status
Recruiting
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Conditions

  • Index Spinal Instrumentation
  • Layer-by-Layer Closure
  • Locoregional Flap-Based Closure
  • Post-Op Complication
  • Site Infection
  • Spinal Instrumentation
  • Spine Surgery
  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chlorhexidine gluconate solution — DEVICE
    Evaluating the prophylactic use of Irrisept irrigation alone
  • Vancomycin — DRUG
    Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Jun 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Irrisept Irrigation
    Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.
  • Active Comparator: Vancomycin-saline Irrigation
    Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.

Primary Outcome Measure

Occurrence of surgical site infection [ Time Frame: 90 days post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903
Alexander Chernysh
[email protected]
401-444-9868
Jared S. Fridley, MD
Albert S. Woo, MD

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