Barrier-Protect Study

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04591366
• Other study ID #: 20200369-01H
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: October 15, 2027

Study information

• Verified date: July 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: October 15, 2027
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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