Intrawound Vancomycin Prophylaxis for Neural Stimulator | NCT03221023

Studies
Intrawound Vancomycin Prophylaxis for Neural Stimulator

NCT03221023

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Oct 30, 2020Actual

Enrollment

900Estimated

Phase

Phase 2Phase 3

Conditions

Vancomycin
Implantable Neural Stimulator
Deep Brain Stimulation
Surgical Site Infection

Interventions

Vancomycin Hydrochloride
Saline Solution

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2017Actual

Primary Completion Date

Sep 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2020

Last Update Posted Date

Oct 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin Hydrochloride	Drug	Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics	Vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christopher R Honey, MD, DPhil	Contact	6048755894		chris.honey@telus.net
Leah Polyhronopoulos, BSc	Contact			leahpoly@mail.ubc.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital	Recruiting	Vancouver	British Columbia	V5Z 1M9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21293168	Background	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.
23474597	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.

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides