Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02284126 · ClinicalTrials.gov registry record · Phase 3
Topical Vancomycin for Neurosurgery Wound Prophylaxis
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,103
- Enrollment target
NCT02284126: Completed Phase 3 study, sponsored by Columbia University.
NCT02284126 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 1,103 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02284126, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,103 participants
- Enrollment target
Study 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
Primary Outcome
Classified as superficial incisional, deep incisional, or organ/space (intradural) infection
Interventions
- DRUG Vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,103 participants |
| Start Date | 2014-10 |
| Est. Completion | 2020-11 |
| Phase | Phase 3 |
What the finished NCT02284126 record still lists
NCT02284126 is an interventional study that assigns participants to a tested intervention. Its 1,103 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 1 intervention - of which Vancomycin is the first listed.
NCT02284126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02284126 about?
NCT02284126 is a clinical study titled "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 eligibl...
What is the current status of trial NCT02284126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,103 participants. The study started on 2014-10. Estimated completion is 2020-11.
What interventions are being tested in trial NCT02284126?
The interventions under investigation include: Vancomycin (DRUG).
Who is sponsoring clinical trial NCT02284126?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02284126's enrollment target sits among peer trials
1,103 252nd of 2000 higher than 1,749 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00710112 · 1,100 participants
Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants
- NCT02688517 · 1,100 participants
Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
- NCT04743765 · 1,100 participants · NA
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
- NCT05638581 · 1,100 participants · Phase 3
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia