Intrawound Vancomycin Prophylaxis for Neural Stimulator

NCT ID: NCT03221023

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2021-12-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vancomycin

These patients will receive intrawound Vancomycin-saline and IV antibiotics

Group Type: EXPERIMENTAL

Vancomycin Hydrochloride

Intervention Type: DRUG

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

Saline Solution

Intervention Type: DRUG

Individuals in the control arm will receive intrawound saline solution

Saline

These patients will receive intrawound saline + IV antibiotics alone

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

Individuals in the control arm will receive intrawound saline solution

Interventions

Vancomycin Hydrochloride

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

Intervention Type: DRUG

Saline Solution

Individuals in the control arm will receive intrawound saline solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christopher Honey

Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Christopher R Honey, MD, DPhil

Role: CONTACT

chris.honey@telus.net

6048755894

Leah Polyhronopoulos, BSc

Role: CONTACT

leahpoly@mail.ubc.ca

References

Doshi PK. Long-term surgical and hardware-related complications of deep brain stimulation. Stereotact Funct Neurosurg. 2011;89(2):89-95. doi: 10.1159/000323372. Epub 2011 Feb 2.

Reference Type: BACKGROUND

PMID: 21293168 (View on PubMed)

Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5.

Reference Type: BACKGROUND

PMID: 23474597 (View on PubMed)

Martin JR, Adogwa O, Brown CR, Kuchibhatla M, Bagley CA, Lad SP, Gottfried ON. Experience with intrawound vancomycin powder for posterior cervical fusion surgery. J Neurosurg Spine. 2015 Jan;22(1):26-33. doi: 10.3171/2014.9.SPINE13826.

Reference Type: BACKGROUND

PMID: 25380539 (View on PubMed)

Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258.

Reference Type: BACKGROUND

PMID: 26424335 (View on PubMed)

Other Identifiers

H16-01496

Identifier Type: -

Identifier Source: org_study_id