InfectionPhase 3VanguardNCT02284126
Topical Vancomycin for Neurosurgery Wound Prophylaxis
A Phase 3 study testing Vancomycin in people with Infection and Surgery, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Surgery, Nervous System Diseases
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,103 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18+) neurosurgical procedure (ie.Craniotomy, Craniectomy, and Cranioplasty)
Who cannot join
- 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
Show all 9Show fewer
- Trans-sphenoidal approach
- Acoustic neuroma resection
- Surgeon preference for or against use in the given procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery
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.
Read the 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.
- Conditions
- Infection, Surgery, Nervous System Diseases
- Being tested
- Vancomycin
- Keywords
- 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
- Medical subject headings
- Infections, Nervous System Diseases, Surgical Wound Infection, Bacterial Infections, Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancomycin Hydrochloride for Injection
Topically applied powder and paste to surgical site at time of closure.
| Study group | Role | What they receive |
|---|---|---|
| Topical Vancomycin | Experimental | 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 Receives: Drug: Vancomycin |
| Standard of Care | No intervention | Control group, receive standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Classified as superficial incisional, deep incisional, or organ/space (intradural) infection
Measured: 30 days & 90 days (+/- 7 days) postoperatively
Number of Subjects That Reported Any Surgical-site Infections
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.
Measured: 30 days & 90 days (+/- 7 days) postoperatively
Secondary outcomes (2)
Number of Participants With Positive Serum Vancomycin Levels
Vancomycin levels in serum will be tested after surgery, any additional fluid collections, but if and only if clinically indicated. A serum vancomycin level of >3.0 mg/dl is considered positive.
Measured: 6-20 hours post-operatively
Number of Participants Who Developed a Previously Undetected Vancomycin Resistance
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.
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2019
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Cornell University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, E. Sander Connolly, Columbia University
- Investigators
- E. Sander Connolly, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284126
- Sponsor's protocol ID
- AAAN3703
- Other IDs
- 1R01HS022903-01
- Acronym
- Vanguard
- Status last verified
- Sep 2025
- First submitted
- 3 Nov 2014
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radwanski RE, Christophe BR, Pucci JU, Martinez MA, Rothbaum M, Bagiella E, Lowy FD, Knopman J, Connolly ES. Topical vancomycin for neurosurgery wound prophylaxis: an interim report of a randomized clinical trial on drug safety in a diverse neurosurgical population. J Neurosurg. 2018 Dec 14;131(6):1966-1973. doi: 10.3171/2018.6.JNS172500. Print 2019 Dec 1.
PubMed 30554184
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Vancomycin for the Reduction of Surgical Site Infections in Neurosurgery
- ClinicalTrials.gov ID
- NCT02284126
- Acronym / sponsor ID
- Vanguard / AAAN3703
- Conditions
- Infection, Surgery, Nervous System Diseases
- Keywords
- Vancomycin, Anti-Infective Agents, Local, Craniotomy, Surgical Site Infection, Wound Prophylaxis, Anti-Bacterial Agents, Neurosurgical Procedures, Administration, Topical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,103 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Cornell University, Icahn School of Medicine at Mount Sinai
- Study start
- Oct 2014
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Vancomycin | Experimental | Drug: VancomycinTreatment 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 |
| Standard of Care | No intervention | –Control group, receive standard of care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18+) neurosurgical procedure (ie.Craniotomy, Craniectomy, and Cranioplasty)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinAlso: Vancomycin Hydrochloride for InjectionTopically applied powder and paste to surgical site at time of closure. | Drug | Topical Vancomycin |
Primary outcome
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.
2 secondary outcomes
Number of Participants With Positive Serum Vancomycin Levels
Time frame: 6-20 hours post-operatively
Number of Participants Who Developed a Previously Undetected Vancomycin Resistance
Time frame: 90 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30554184Radwanski RE, Christophe BR, Pucci JU, Martinez MA, Rothbaum M, Bagiella E, Lowy FD, Knopman J, Connolly ES. Topical vancomycin for neurosurgery wound prophylaxis: an interim report of a randomized clinical trial on drug safety in a diverse neurosurgical population. J Neurosurg. 2018 Dec 14;131(6):1966-1973. doi: 10.3171/2018.6.JNS172500. Print 2019 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Sander Connolly, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin in people with Infection and Surgery, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.