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Completed

NCT Number: NCT02284126

Topical Vancomycin for Neurosurgery Wound Prophylaxis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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 health care 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. 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 pre-operative 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. Our unpublished analysis of the National Inpatient Sample (NIS) in 2010 identified 117,000 craniotomies with a 2.4% rate of infection and 1.37% rate of Methicillin-resistant Staphylococcus aureus (MRSA)-associated infection. Extrapolating to the full national population, there were 585,000 craniotomies and 14,040 post-operative infections. Published series report the rate of infection in intracranial neurosurgery to range from 1% to as high as 11%. This rate varies depending on the presence of hardware, prior radiotherapy, procedure duration, re-operation, and the presence of a CSF leak. The 30-day outcome associated with SSI following craniotomy was recently reported to be a minor disability in 12.8%, major disability in 7.7% and death in 5.1%. The financial burden of nosocomial infection in neurosurgery makes up a disproportionate component of the total national cost burden. A study of nosocomial infection in the US in 1995 estimated a per-patient cost of $2100 and a total cost of $4.5 billion while a recent British study focusing on post-craniotomy SSI identified a per-SSI cost of £9283, or $14,166. Given the tremendous potential for lifelong morbidity and mortality as a result of cranial SSIs, further reductions in the rate of SSI would be essential for the benefit of neurosurgical patients, as well as for the healthcare system as a whole.Topical formulations of vancomycin offer the possibility of direct application to the surgical wound, with minimal additional systemic drug exposure. Adjunctive vancomycin powder applied topically to surgical wound edges has been shown to significantly lower the SSI rate in both cardiothoracic surgery and spinal surgery. Importantly, laboratory analyses of blood and wound drainage samples from patients treated with vancomycin powder have demonstrated high vancomycin concentrations in the surgical wound, and simultaneously low drug concentrations in the peripheral blood, thereby confirming minimal systemic absorption in the setting of enhanced protection of the surgical site. Furthermore, there have been no reports of an increased rate of drug-related complications with the addition of vancomycin powder to standard antibiotic prophylaxis regimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Topically applied powder and paste to surgical site at time of closure.

Other names: Vancomycin Hydrochloride for Injection

Primary outcomes

  1. 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

    Time frame: 30 days & 90 days (+/- 7 days) postoperatively

    Classified as superficial incisional, deep incisional, or organ/space (intradural) infection

  2. Number of Subjects That Reported Any Surgical-site Infections

    Time frame: 30 days & 90 days (+/- 7 days) postoperatively

    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. Classified as superficial incisional, deep incisional, or organ/space (intradural) infection.

Secondary outcomes

  1. Number of Participants With Positive Serum Vancomycin Levels

    Time frame: 6-20 hours post-operatively

    Vancomycin levels in serum will be tested after surgery, any additional fluid collections, but if and only if clinically indicated. A serum vancomycin level of >3.0 mg/dl is considered positive.

  2. Number of Participants Who Developed a Previously Undetected Vancomycin Resistance

    Time frame: 90 days postoperatively

    Microbial swabs will be obtained by the clinical coordinator preoperatively, post-operatively, at 10-14 days and at 90 days. Staph aureus isolates from mannitol growth will be tested for vancomycin resistance.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Cornell University
  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery

Acronym: Vanguard

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 5, 2014
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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