Barrier-Protect Study

Not Applicable

Active, not recruiting

• Conditions: Infection
• Interventions: Other: Barrier dressing

• Registration Number: NCT04591366
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2020-11-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 390

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Barrier dressing	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.
Control	Barrier dressing	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.

Primary Outcome Measures

Name	Time	Method
End of surgery pocket swab culture positivity	one month post procedure	To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection

Secondary Outcome Measures

Name	Time	Method
CIED infection, defined as in the recent PADIT trial	Year 1 and 2 post procedure	1. 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); 2. 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).; 3. Bloodstream infections will be defined according to 2008 NHSN and US CDC definitions for Primary bloodstream infections (33)

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada