Irrisept Solution for Instrumented Spine Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital

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 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

Qualifiers

Age: 18+ years old

Indications: deformity, oncologic, degenerative, trauma

Standard layer-by-layer closure

Locoregional flap-based closure

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Chlorhexidine gluconate solution
  • Vancomycin

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators