Intrawound Vancomycin Prophylaxis for Neural Stimulator

Phase 2

• Conditions: Surgical Site Infection; Vancomycin; Deep Brain Stimulation; Implantable Neural Stimulator
• Interventions: Drug: Vancomycin Hydrochloride; Drug: Saline Solution

• Registration Number: NCT03221023
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Study Start: 2017-09-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30
• Primary Completion: 2021-09-15
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Saline Solution	These patients will receive intrawound Vancomycin-saline and IV antibiotics
Vancomycin	Vancomycin Hydrochloride	These patients will receive intrawound Vancomycin-saline and IV antibiotics
Saline	Saline Solution	These patients will receive intrawound saline + IV antibiotics alone

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada