NCT04591366

Barrier-Protect Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-11-25
• Primary completion: 2026-10-15
• Completion: 2027-10-15
• First posted: 2020-10-19
• Last updated: 2024-07-17

Locations

1 site across 1 country: Canada