Topical Vancomycin for Neurosurgery Wound Prophylaxis



Status:Recruiting
Conditions:Infectious Disease, Neurology
Therapuetic Areas:Immunology / Infectious Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:6/17/2016
Start Date:October 2014
End Date:October 2019
Contact:Moises A Martinez, B.A.
Email:mm4512@cumc.columbia.edu
Phone:212-305-4679

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Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery

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.

Surgical-site infections (SSIs) occur in up to 500,000 patients per year in the United
States. Patients with SSIs require significantly longer hospital stays and higher healthcare
expenditures. In fact, it is estimated that SSIs are responsible for almost 4 million excess
hospital days and billions of dollars in added hospital charges every year. Additionally,
SSIs are a significant source of morbidity and mortality for surgical patients (5,8). Thus,
prompt and definitive measures are necessary in order to redress this significant public
health concern. Over the past few decades, the implementation of a number of preventative
measures—including improved techniques in preoperative skin antisepsis and antibiotic
prophylaxis —have led to significant reductions in the rate of SSIs. Studies have
demonstrated that approximately half of all SSIs are preventable with the proper use of
prophylactic antibiotics. Despite these dramatic improvements, SSIs remain a tremendous
burden on the healthcare system. Furthermore, routine use of systemic antibiotic prophylaxis
is not without risks, as it may lead to rapid development of antibiotic resistance, and also
exposes patients to undesirable systemic drug effects. The purpose of this study is to
evaluate the ability of topical vancomycin to reduce surgical site infections after
neurosurgical operations.

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)

- 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
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: E. Sander Connolly, MD
Phone: 212-305-4679
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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