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Active, Not Recruiting

NCT Number: NCT04591366

Barrier-Protect Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Barrier dressing

Other

A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.

Primary outcomes

  1. 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

  1. CIED infection, defined as in the recent PADIT trial

    Time frame: Year 1 and 2 post procedure

    • 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)

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 19, 2020
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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