Infection
Conditions
Keywords
Cardiac, Device
Brief 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.
Interventions
OTHERBarrier dressing
A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and staff taking the swab will be blinded as to the randomization allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged 18 2. Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket. 3. PADIT risk score ≥ 5
Exclusion criteria
1. Unable or unwilling to provide informed consent. 2. De novo device implantation. 3. Active device infection. 4. Iodine allergy 5. Life expectancy less than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of surgery pocket swab culture positivity | one month post procedure | To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIED infection, defined as in the recent PADIT trial | Year 1 and 2 post procedure | 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) |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAlper Aydin, Dr.
Ottawa Heart Institute Research Corporation
Outcome results
None listed