Intrawound Vancomycin Prophylaxis for Neural Stimulator

NCT03221023 | Unknown Phase 2 FDA Drug

• 1 other identifier: H16-01496
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Device explantation 6 months post surgery

  The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, "was the INS device explanted", will be answered.

  6 months

Study Arms (2)

Vancomycin

EXPERIMENTAL

These patients will receive intrawound Vancomycin-saline and IV antibiotics

Drug: Vancomycin Hydrochloride; Drug: Saline Solution

Saline

PLACEBO COMPARATOR

These patients will receive intrawound saline + IV antibiotics alone

Drug: Saline Solution

Interventions

Vancomycin Hydrochloride DRUG

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

Vancomycin

Saline Solution DRUG

Individuals in the control arm will receive intrawound saline solution

Saline; Vancomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 21293168 BACKGROUND

• 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.

  PMID: 23474597 BACKGROUND

• 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.

  PMID: 25380539 BACKGROUND

• 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.

  PMID: 26424335 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Vancomycin; Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Christopher R Honey, MD, DPhil

CONTACT

6048755894; chris.honey@telus.net

Leah Polyhronopoulos, BSc

CONTACT

leahpoly@mail.ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both patient and surgeon will be blinded to the treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Model Details: The subjects meeting the inclusion criteria will be randomized to either the treatment arm or the control arm by site in a 1:1 ratio.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: September 15, 2017
• Primary Completion: September 15, 2021
• Study Completion: December 15, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)