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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Irrisept IrrigationExperimental treatment 1 intervention
Group B: Vancomycin-saline IrrigationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of surgical site infection

Development of infection after index spinal instrumentation

Time frame
90 days post-operatively

Secondary outcomes

1

Mortality

Capture mortality rates after index spinal instrumentation

Time frame
12 months post-operatively
2

Duration of index hospitalization

Capture duration of index hospitalization after index spinal instrumentation

Time frame
12 months post-operatively
3

Occurrence of 30-day readmission

Capture 30-day readmission rates after index spinal instrumentation

Time frame
30 days post-operatively
4

Occurrence of wound dehiscence

Capture all incidences of wound dehiscence after index spinal instrumentation

Time frame
12 months post-operatively

Other outcomes

Sponsors and contacts

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