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Barrier-Protect Study

Primary Purpose

Infection

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Barrier dressing

About this trial

This is an interventional prevention trial for Infection focused on measuring Cardiac, Device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

End of surgery pocket swab culture positivity

To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT04591366

First Posted

October 2, 2020

Last Updated

July 6, 2023

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04591366

Brief Title

Barrier-Protect Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 25, 2020 (Actual)

Primary Completion Date

October 15, 2026 (Anticipated)

Study Completion Date

October 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection

Keywords

Cardiac, Device

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

Participants and staff taking the swab will be blinded as to the randomization allocation.

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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 Type

Other

Intervention Name(s)

Barrier dressing

Intervention Description

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

Primary Outcome Measure Information:

Title

End of surgery pocket swab culture positivity

Description

To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection

Time Frame

one month post procedure

Secondary Outcome Measure Information:

Title

CIED infection, defined as in the recent PADIT trial

Description

Time Frame

Year 1 and 2 post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alper Aydin, Dr.

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Barrier-Protect Study

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