Barrier-Protect Study

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04591366
Collaborator
(none)
390
1
2
82.6
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Barrier dressing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants and staff taking the swab will be blinded as to the randomization allocation.
Primary Purpose:
Prevention
Official Title:
Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
Actual Study Start Date :
Nov 25, 2020
Anticipated Primary Completion Date :
Oct 15, 2026
Anticipated Study Completion Date :
Oct 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

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

Experimental: Intervention

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. CIED infection, defined as in the recent PADIT trial [Year 1 and 2 post procedure]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7

Sponsors and Collaborators

  • Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Alper Aydin, Dr., Ottawa Heart Institute Research Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT04591366
Other Study ID Numbers:
  • 20200369-01H
First Posted:
Oct 19, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ottawa Heart Institute Research Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022