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Intrawound Vancomycin Prophylaxis for Neural Stimulator

NCT03221023 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2020-10-30

No results posted yet for this study

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

Interventions

DRUG

Vancomycin Hydrochloride

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

DRUG

Saline Solution

Individuals in the control arm will receive intrawound saline solution

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2021-09-15
Completion
2021-12-15
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221023 on ClinicalTrials.gov