NCT03221023

Intrawound Vancomycin Prophylaxis for Neural Stimulator

Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vancomycin
• Implantable Neural Stimulator
• Deep Brain Stimulation
• Surgical Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-15
• Primary completion: 2021-09-15
• Completion: 2021-12-15
• First posted: 2017-07-18
• Last updated: 2020-10-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study