Intrawound Vancomycin Prophylaxis for Neural Stimulator

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03221023
Study type	Interventional
Source	University of British Columbia
Contact	Christopher R Honey, MD, DPhil
Phone	6048755894
Email	chris.honey@telus.net
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 15, 2017
Completion date	December 15, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intrawound Vancomycin Prophylaxis for Neural Stimulator — IV-DIRT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms