Barrier-Protect Study

NCT04591366 | Active Not Recruiting

• 1 other identifier: 20200369-01H
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Cardiac; Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CIED infection, defined as in the recent PADIT trial

  Year 1 and 2 post procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

Barrier dressing OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to provide informed consent.
• De novo device implantation.
• Active device infection.
• Iodine allergy
• Life expectancy less than 2 years

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• Aydin A, Golian M, Klein A, Redpath C, Davis DR, Ramirez FD, Nair GM, Green MS, Sadek M, Nery PB, Hansom SP, Al Hinai G, Weng W, Berbenetz N, Thibert MJ, Salmeen Y, Martow E, Tan LW, Almidani G, Alshehri A, Alzahrani A, Alharbi F, Corrales-Medina V, Wells GA, Birnie DH. Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1016-1023. doi: 10.1001/jamacardio.2025.2835.

  PMID: 40864462 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Alper Aydin, Dr.

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and staff taking the swab will be blinded as to the randomization allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: November 25, 2020
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)