Intrawound Vancomycin Prophylaxis for Neural Stimulator (IV-DIRT)

University of British Columbia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Vancomycin; Surgical Site Infection; Implantable Neural Stimulator; Deep Brain Stimulation

Treatments: Drug: Saline Solution; Drug: Vancomycin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03221023

H16-01496

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 2 patient groups, including a placebo group

Vancomycin

Experimental group

Description:

These patients will receive intrawound Vancomycin-saline and IV antibiotics

Treatment:

Drug: Saline Solution

Drug: Vancomycin Hydrochloride

Saline

Placebo Comparator group

Description:

These patients will receive intrawound saline + IV antibiotics alone

Treatment:

Drug: Saline Solution