Recruiting
Phase 2
Phase 3

Vancomycin Prophylaxis

Sponsor:

University of British Columbia

Code:

NCT03221023

Conditions

Vancomycin

Implantable Neural Stimulator

Deep Brain Stimulation

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vancomycin Hydrochloride

Saline Solution

Study Details

Brief summary:

The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.

Conditions

Vancomycin

Implantable Neural Stimulator

Deep Brain Stimulation

Surgical Site Infection

Study ID

NCT03221023

Start date

Sep 15, 2017

Status verified date

Oct, 2020

Completion date

Dec 15, 2021

Anticipated

Primary completion date

Sep 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • individuals who require INS replacement from Dr. C.R. Honey
  • individuals who are between the ages of 18 to 80.
  • individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon
  • individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively
  • individuals who are capable of providing informed consent

Exclusion Criteria:

  • individuals who have a history of autoimmune disease
  • individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study
  • individuals who are on immunosuppression or any medication that would influence infection susceptibility
  • individuals who are allergic to Vancomycin or Cefazolin

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Vancomycin

These patients will receive intrawound Vancomycin-saline and IV antibiotics

placebo comparator: Saline

These patients will receive intrawound saline + IV antibiotics alone

Interventions

Vancomycin Hydrochloride

Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics

Saline Solution

Individuals in the control arm will receive intrawound saline solution

Primary outcome measure

  • Device explantation 6 months post surgery [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Christopher R Honey, MD, DPhil

6048755894chris.honey@telus.net

Leah Polyhronopoulos, BSc

leahpoly@mail.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

More Information

Sponsor

University of British Columbia

Last update posted

Oct 30, 2020

Last verified

Oct, 2020

Keywords

  • Vancomycin
  • Implantable Neural Stimulator
  • Deep Brain Stimulation
  • Surgical Site Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-10-30.