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Topical Vancomycin for Neurosurgery Wound Prophylaxis (Vanguard)

This study is currently recruiting participants.
Verified February 2017 by E. Sander Connolly, Columbia University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284126
First Posted: November 5, 2014
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Cornell University
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
E. Sander Connolly, Columbia University
  Purpose
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.

Condition Intervention Phase
Infection Surgery Nervous System Diseases Drug: Vancomycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery

Resource links provided by NLM:


Further study details as provided by E. Sander Connolly, Columbia University:

Primary Outcome Measures:
  • 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 postoperatively (90 days if implant) ]
    Classified as superficial incisional, deep incisional, or organ/space (intradural) infection


Secondary Outcome Measures:
  • Serum vancomycin levels [ Time Frame: 6-24 hours post-operatively ]
    Vancomycin levels in serum will be tested after surgery, any additional fluid collections, but if and only if clinically indicated

  • Development of 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 with an MIC test, comparing preoperative baseline and postoperative timepoints for development of increased vancomycin resistance


Estimated Enrollment: 3600
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Vancomycin
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Drug: Vancomycin
Topically applied powder and paste to surgical site at time of closure.
Other Name: Vancomycin Hydrochloride for Injection
No Intervention: Standard of Care
Control group, receive standard of care only

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284126


Contacts
Contact: Moises A Martinez, B.A. 212-305-4679 mm4512@cumc.columbia.edu
Contact: Brandon R Christophe, B.A. 212-305-4679 brc2119@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Moises Martinez, B.A.    212-305-4679    mm4512@cumc.columbia.edu   
Principal Investigator: E. Sander Connolly, MD         
Sponsors and Collaborators
Columbia University
Agency for Healthcare Research and Quality (AHRQ)
Cornell University
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: E. Sander Connolly, M.D. Columbia University
  More Information

Responsible Party: E. Sander Connolly, Bennett M. Stein Professor of Neurological Surgery; Vice Chairman of Neurosurgery; Director, Cerebrovascular Research Laboratory; Surgical Director, Neuro-Intensive Care Unit, Columbia University
ClinicalTrials.gov Identifier: NCT02284126     History of Changes
Other Study ID Numbers: AAAN3703
1R01HS022903-01 ( U.S. AHRQ Grant/Contract )
First Submitted: November 3, 2014
First Posted: November 5, 2014
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by E. Sander Connolly, Columbia University:
Vancomycin
Anti-Infective Agents, Local
Craniotomy
surgical site infection
wound prophylaxis
Anti-Bacterial Agents
Neurosurgical Procedures
Administration, Topical
Antibiotic Prophylaxis
antibiotics
prophylaxis
neurosurgery
Bacterial Infections
Central Nervous System Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Nervous System Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents