Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- End of surgery pocket swab culture positivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Masking Description
Participants and staff taking the swab will be blinded as to the randomization allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged 18
- •Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket.
- •PADIT risk score ≥ 5
Exclusion Criteria
- •Unable or unwilling to provide informed consent.
- •De novo device implantation.
- •Active device infection.
- •Iodine allergy
- •Life expectancy less than 2 years
Arms & Interventions
Control
Standard skin prep prior to procedure will be performed and an adhesive iodine-infused barrier dressing will be applied post procedure but prior to taking the culture swab and closing the incision.
Intervention: Barrier dressing (Other)
Intervention
Standard skin prep prior to procedure plus an adhesive iodine-infused barrier dressing prior to incision, post procedure a culture swab will be taken and the incision closed.
Intervention: Barrier dressing (Other)
Outcomes
Primary Outcomes
End of surgery pocket swab culture positivity
Time Frame: one month post procedure
To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection
Secondary Outcomes
- CIED infection, defined as in the recent PADIT trial(Year 1 and 2 post procedure)