Barrier-Protect Study

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

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 Overview

• Status: Active, not recruiting
• Conditions: Infection
• Intervention / Treatment: Other: Barrier dressing

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Page; Phone Number: 14296 613-696-7000; Email: NanPage@ottawaheart.ca
• Study Contact Backup: Name: Alper Aydin, Dr.; Phone Number: 613-696-7058; Email: Aaydin@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Alper Aydin, Dr., Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Device; Cardiac
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 20200369-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No