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Trial record 40 of 530 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

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.

Condition or disease Intervention/treatment Phase
Vancomycin Implantable Neural Stimulator Deep Brain Stimulation Surgical Site Infection Drug: Vancomycin Hydrochloride Drug: Saline Solution Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
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
Official Title: Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vancomycin
These patients will receive intrawound Vancomycin-saline and IV antibiotics
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

Placebo Comparator: Saline
These patients will receive intrawound saline + IV antibiotics alone
Drug: Saline Solution
Individuals in the control arm will receive intrawound saline solution




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221023


Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia

Publications:
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Responsible Party: Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British Columbia
ClinicalTrials.gov Identifier: NCT03221023     History of Changes
Other Study ID Numbers: H16-01496
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Christopher Honey, University of British Columbia:
Vancomycin
Implantable Neural Stimulator
Deep Brain Stimulation
Surgical Site Infection
Additional relevant MeSH terms:
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Surgical Wound Infection
Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Anti-Infective Agents