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Trial record 40 of 532 for:    VANCOMYCIN

Intrawound Vancomycin Prophylaxis for Neural Stimulator (IV-DIRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221023
Recruitment Status : Enrolling by invitation
First Posted : July 18, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Device explantation 6 months post surgery [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03221023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrawound Vancomycin Prophylaxis for Neural Stimulator
Official Title  ICMJE Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Care Provider)
Masking Description:
Both patient and surgeon will be blinded to the treatment.
Primary Purpose: Prevention
Condition  ICMJE
  • Vancomycin
  • Implantable Neural Stimulator
  • Deep Brain Stimulation
  • Surgical Site Infection
Intervention  ICMJE
  • Drug: Vancomycin Hydrochloride
    Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
  • Drug: Saline Solution
    Individuals in the control arm will receive intrawound saline solution
Study Arms  ICMJE
  • Experimental: Vancomycin
    These patients will receive intrawound Vancomycin-saline and IV antibiotics
    Interventions:
    • Drug: Vancomycin Hydrochloride
    • Drug: Saline Solution
  • Placebo Comparator: Saline
    These patients will receive intrawound saline + IV antibiotics alone
    Intervention: Drug: Saline Solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221023
Other Study ID Numbers  ICMJE H16-01496
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Honey, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP