Topical Vancomycin for Neurosurgery Wound Prophylaxis
Condition: Infection; Surgery; Nervous System Diseases
MeSH terms: Infections; Communicable Diseases; Nervous System Diseases
Intervention: Vancomycin
Intervention description: Topically applied powder and paste to surgical site at time of closure.
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vancomycin; Anti-Infective Agents, Local; Craniotomy; Surgical Site Infection; Wound Prophylaxis; Anti-Bacterial Agents; Neurosurgical Procedures; Administration, Topical; Antibiotic Prophylaxis; Antibiotics; Prophylaxis; Neurosurgery; Bacterial Infections; Central Nervous System Infections

Summary:

      This study is a collaboration between New York Presbyterian (NYP)-Columbia and NYP-Cornell
      that seeks to evaluate the use of topical vancomycin and its reduction on surgical site
      infection (SSI) in neurosurgical procedures. Adult patients undergoing neurosurgery at either
      institution will be eligible for participation in this randomized control trial. Patients
      randomized to the treatment group will receive 2g of vancomycin applied as a powder or paste
      to the wound site and/or bone flap. Subjects in the control group will receive the current
      standard of care without topical vancomycin. All subjects will undergo swabbing of the
      anterior nares and the surgical site prior to surgery, once 10-14 days following the
      operation and 90 days following the operation. The primary outcome measure will be surgical
      site infection, assessed daily throughout the hospital stay, at the first follow-up visit,
      and by telephone at 14-30 days and 90 days (+/- 7 days). Secondary outcomes will include
      length of hospital stay, length of intensive care stay, rate of reoperation and patient
      mortality. In addition, systemic vancomycin levels will be assessed at 6 hours and 20 hours
      postoperatively in each patient. Patients who have an external ventricular drain in place
      will have vancomycin levels assessed daily. In patients who have cranial drains placed,
      vancomycin concentrations will be analyzed from daily in wound drainage. Skin and nasal flora
      will be analyzed to assess the impact of topical vancomycin on the patient microbiome.
      Although there has been a decrease in the incidence of infections following craniotomy
      secondary to prophylactic intravenous antibiotics, proper sterile techniques, and other
      interventions, SSIs continue to significantly impact morbidity, mortality, and cost burden.
      Although never studied in neurosurgical procedures other than instrumented spine, the
      application of topical vancomycin to the surgical site prior to wound closure has
      demonstrated a reduction in SSIs in spine, cardiac and ophthalmologic procedures. The
      benefits of using prophylactic vancomycin topically, as opposed to intravenously, include
      reduced systemic levels of the drug, and therefore, a decreased probability of adverse events
      related to the drug, such as inducing resistance among the native flora. The investigators
      propose a single-blinded randomized control trial to evaluate the effectiveness of topical
      vancomycin in reducing SSIs rates following neurosurgical procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (18+) neurosurgical procedure (ie.Craniotomy, Craniectomy, and Cranioplasty)

        Exclusion Criteria:

          -  Creatinine > 1.50 mg/dL on admission

          -  Vancomycin allergy (documented or self-reported)

          -  Evidence of infection at or near the planned surgical site

          -  No planned dural or dural-substitute closure

          -  Spinal instrumentation (topical vancomycin is already standard of care)

          -  No surface area to apply:Carotid endarterectomy, MRI-guided laser ablation

          -  Trans-sphenoidal approach

          -  Acoustic neuroma resection

          -  Surgeon preference for or against use in the given procedure