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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
390
A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
End of surgery pocket swab culture positivity
To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection
Time frame: one month post procedure
CIED infection, defined as in the recent PADIT trial
1. Pocket infection: Nosocomial surgical site infection will be defined according to the 2008 National Healthcare Safety Network (NHSN) and US CDC definitions for superficial and deep surgical site infections (30) 2. Endocarditis will be diagnosed according to the Modified Dukes' criteria (31). These were adapted by Klug D et al. to diagnose endocarditis in patients with implantable cardiac devices (32). 3. Bloodstream infections will be defined according to 2008 NHSN and US CDC definitions for Primary bloodstream infections (33)
Time frame: Year 1 and 2 post procedure
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