Status:
COMPLETED
Topical Vancomycin for Neurosurgery Wound Prophylaxis
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Cornell University
Conditions:
Infection
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ne...
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 fa...
Eligibility Criteria
Inclusion
- Adult (18+) neurosurgical procedure (ie.Craniotomy, Craniectomy, and Cranioplasty)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
1103 Patients enrolled
Trial Details
Trial ID
NCT02284126
Start Date
October 1 2014
End Date
November 1 2020
Last Update
October 29 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032