Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
Conditions
Keywords
Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
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.
Detailed description
Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death. The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery. This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked. The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.
Interventions
Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
DRUGSaline Solution
Individuals in the control arm will receive intrawound saline solution
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both patient and surgeon will be blinded to the treatment.
Intervention model description
The subjects meeting the inclusion criteria will be randomized to either the treatment arm or the control arm by site in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device explantation 6 months post surgery | 6 months | The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, was the INS device explanted, will be answered. |
Countries
Canada
Contacts
Primary ContactChristopher R Honey, MD, DPhil
Backup ContactLeah Polyhronopoulos, BSc
Outcome results
None listed