Intrawound Vancomycin Prophylaxis for Neural Stimulator

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Anti-Bacterial Agents; Vancomycin

Criteria

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