Topical Vancomycin for Neurosurgery Wound Prophylaxis
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Surgery; Nervous System Diseases
Intervention: Vancomycin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s): E. Sander Connolly, M.D., Principal Investigator, Affiliation: Columbia University
Overall contact: Alexander J Jonokuchi, B.A., Phone: 2123054679, Email: ajj2120@cumc.columbia.edu
Summary
This study is a collaboration between 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 30 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 24 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 native flora. The investigators propose a randomized control trial
to evaluate the effectiveness of topical vancomycin in reducing SSIs rates following
neurosurgical procedures.
Clinical Details
Official title: Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Any surgical-site infection as evidenced by surgeon or attending physician diagnosis, or signs and symptoms of infection assessed by phone call interview or at in-office follow-up consultation
Secondary outcome: Serum vancomycin levelsDevelopment of previously undetected vancomycin resistance
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult (18+) neurosurgical procedure
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)
- Carotid endarterectomy
- Trans-sphenoidal approach
- Acoustic neuroma resection
Locations and Contacts
Alexander J Jonokuchi, B.A., Phone: 2123054679, Email: ajj2120@cumc.columbia.edu
Columbia University Medical Center, New York, New York 10032, United States; Recruiting Theresa Vanni-Reyes, B.S., Phone: 212-305-8101, Email: tv1@columbia.edu E. Sander Connolly, MD, Principal Investigator
Additional Information
Starting date: October 2014
Last updated: February 3, 2015
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