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Barrier-Protect Study
Sponsor: Ottawa Heart Institute Research Corporation
Summary
This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the implant procedure can be one of the potential improvements to prevent CIED infections. Patients requiring a lead change, battery change or device upgrade will be eligible. This is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). Patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.
Official title: Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2020-11-25
Completion Date
2027-10-15
Last Updated
2024-07-17
Healthy Volunteers
No
Conditions
Interventions
Barrier dressing
A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.
Locations (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada