Barrier-Protect Study

Study Overview
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Brief Summary
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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
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Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial

Conditions
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Infection

Intervention / Treatment
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* Other: Barrier dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Other: Barrier dressing<br>* A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.<br>|
| Experimental: Intervention<br>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. | Other: Barrier dressing<br>* A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of surgery pocket swab culture positivity | To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection | one month post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIED infection, defined as in the recent PADIT trial | 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) 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). Bloodstream infections will be defined according to 2008 NHSN and US CDC definitions for Primary bloodstream infections (33) | Year 1 and 2 post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac, Device