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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Chlorhexidine gluconate solution
DeviceEvaluating the prophylactic use of Irrisept irrigation alone
Vancomycin
DrugEvaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of surgical site infection
Development of infection after index spinal instrumentation
Secondary outcomes
Mortality
Capture mortality rates after index spinal instrumentation
Duration of index hospitalization
Capture duration of index hospitalization after index spinal instrumentation
Occurrence of 30-day readmission
Capture 30-day readmission rates after index spinal instrumentation
Occurrence of wound dehiscence
Capture all incidences of wound dehiscence after index spinal instrumentation
Sponsors and contacts
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