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 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 1,103 participants.
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
Interventions
- DRUG Vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,103 participants |
| Start Date | 2014-10 |
| Est. Completion | 2020-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02284126
The ClinicalTrials.gov registry entry for NCT02284126 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vancomycin is the first listed.
NCT02284126 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.