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Topical Vancomycin for Neurosurgery Wound Prophylaxis (Vanguard)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284126
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Results First Posted : January 25, 2021
Last Update Posted : March 23, 2021
Sponsor:
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infection Surgery Nervous System Diseases Drug: Vancomycin Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1103 participants
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
Study Start Date : October 2014
Actual Primary Completion Date : November 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. 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. The data is collected post-operative and will not be analyzed until the end of the study with another collaborator using Statewide Planning and Research Cooperative System (SPARCS) and New York State (NYS) datasets.

  2. 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, comparing preoperative baseline and postoperative timepoints for development of increased vancomycin resistance. The data is collected post-operative and will not be analyzed until the end of the study with another collaborator using SPARCS and NYS datasets.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Agency for Healthcare Research and Quality (AHRQ)
Cornell University
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: E. Sander Connolly, M.D. Columbia University
  Study Documents (Full-Text)

Documents provided by E. Sander Connolly, Columbia University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    
Other Study ID Numbers: AAAN3703
1R01HS022903-01 ( U.S. AHRQ Grant/Contract )
First Posted: November 5, 2014    Key Record Dates
Results First Posted: January 25, 2021
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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:
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Infections
Communicable Diseases
Nervous System Diseases
Disease Attributes
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents