Topical Vancomycin for Neurosurgery Wound Prophylaxis
Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Columbia University
Collaborators:
Agency for Healthcare Research and Quality (AHRQ) Cornell University Icahn School of Medicine at Mount Sinai