Intrawound Vancomycin Prophylaxis for Neural Stimulator — IV-DIRT  

Surgical Site Infection Clinical Trial

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

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. ;

Related Conditions & MeSH terms

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

• 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