Topical Vancomycin for Neurosurgery Wound Prophylaxis

NCT02284126 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: AAAN37031R01HS022903-01
• Study Type: interventional
• Target: 1,103
• Locations: 1 country
• Sites: 1

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 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.

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; Antibiotic Prophylaxis; Antibiotics; Prophylaxis; Neurosurgery; Bacterial Infections; Central Nervous System Infections

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  30 days & 90 days (+/- 7 days) postoperatively

Secondary Outcomes (2)

• Number of Participants With Positive Serum Vancomycin Levels

  6-20 hours post-operatively

• Number of Participants Who Developed a Previously Undetected Vancomycin Resistance

  90 days postoperatively

Study Arms (2)

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

Drug: Vancomycin

Standard of Care

NO INTERVENTION

Control group, receive standard of care only

Interventions

Vancomycin DRUG

Topically applied powder and paste to surgical site at time of closure.

Also known as: Vancomycin Hydrochloride for Injection

Topical Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18+) neurosurgical procedure (ie.Craniotomy, Craniectomy, and Cranioplasty)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Cornell University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 30554184 DERIVED

MeSH Terms

Conditions

Infections; Nervous System Diseases; Surgical Wound Infection; Bacterial Infections; Central Nervous System Infections

Interventions

Vancomycin; Injections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. E. Sander Connolly Jr.
• Organization: Columbia University Irving Medical Center

esc5@cumc.columbia.edu

2123054118

Study Officials

• E. Sander Connolly, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bennett M. Stein Professor of Neurological Surgery Vice Chairman of Neurosurgery Director, Cerebrovascular Research Laboratory Surgical Director, Neuro-Intensive Care Unit

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: October 29, 2025
• Results First Posted: January 25, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)