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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


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 levels

Development of previously undetected vancomycin resistance


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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