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
|Condition or disease||Intervention/treatment||Phase|
|Infection Surgery Nervous System Diseases||Drug: Vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
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
- 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
- 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.
- 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.
- 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.
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
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||E. Sander Connolly, M.D.||Columbia University|