Intrawound Vancomycin Prophylaxis for Neural Stimulator (IV-DIRT)
Primary Purpose
Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vancomycin Hydrochloride
Saline Solution
Sponsored by
About this trial
This is an interventional prevention trial for Vancomycin focused on measuring Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
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
Sites / Locations
- Vancouver General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vancomycin
Saline
Arm Description
These patients will receive intrawound Vancomycin-saline and IV antibiotics
These patients will receive intrawound saline + IV antibiotics alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03221023
First Posted
July 12, 2017
Last Updated
October 29, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03221023
Brief Title
Intrawound Vancomycin Prophylaxis for Neural Stimulator
Acronym
IV-DIRT
Official Title
Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
Keywords
Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
Both patient and surgeon will be blinded to the treatment.
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
These patients will receive intrawound Vancomycin-saline and IV antibiotics
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
These patients will receive intrawound saline + IV antibiotics alone
Intervention Type
Drug
Intervention Name(s)
Vancomycin Hydrochloride
Intervention Description
Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
Individuals in the control arm will receive intrawound saline solution
Primary Outcome Measure Information:
Title
Device explantation 6 months post surgery
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher R Honey, MD, DPhil
Phone
6048755894
Email
chris.honey@telus.net
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Polyhronopoulos, BSc
Email
leahpoly@mail.ubc.ca
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21293168
Citation
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.
Results Reference
background
PubMed Identifier
23474597
Citation
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.
Results Reference
background
PubMed Identifier
25380539
Citation
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.
Results Reference
background
PubMed Identifier
26424335
Citation
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.
Results Reference
background
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Intrawound Vancomycin Prophylaxis for Neural Stimulator
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