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Barrier Dressing for Infections

N/A
Waitlist Available
Led By Alper Aydin, Dr.
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1 and 2 post procedure
Awards & highlights

Study Summary

This trial is testing whether an iodine-soaked dressing can help prevent infection around a pacemaker or defibrillator.

Who is the study for?
The Barrier-Protect Study is for adults over 18 who need a second or later heart device procedure, like battery change or lead revision, and have a moderate risk of infection. It's not for first-time implant patients, those with current infections, life expectancy under two years, iodine allergies, or if they can't consent.Check my eligibility
What is being tested?
This study tests an iodine barrier dressing applied before incision to see if it reduces germs in the wound during heart device procedures. Participants are randomly chosen to get the dressing early (experimental) or just before swabbing (control), without knowing which group they're in.See study design
What are the potential side effects?
Since this trial involves an external barrier dressing rather than medication, side effects may be minimal but could include skin irritation or allergic reaction to iodine for those not previously identified with an allergy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had previous surgery to adjust or change an implanted device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1 and 2 post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 and 2 post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
End of surgery pocket swab culture positivity
Secondary outcome measures
CIED infection, defined as in the recent PADIT trial

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,184 Total Patients Enrolled
Alper Aydin, Dr.Principal InvestigatorOttawa Heart Institute Research Corporation

Media Library

Barrier dressing Clinical Trial Eligibility Overview. Trial Name: NCT04591366 — N/A
Infections Research Study Groups: Control, Intervention
Infections Clinical Trial 2023: Barrier dressing Highlights & Side Effects. Trial Name: NCT04591366 — N/A
Barrier dressing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04591366 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants currently being recruited for this research project?

"Affirmative, clinicaltrials.gov's information verifies that this medical trial is in the process of patient enrollment. This study was originally uploaded on November 25th 2020 and made its latest revision on February 9th 2022. The research project requires 390 participants to be recruited from a single location."

Answered by AI

What is the size of the cohort currently engaged in this research endeavor?

"Affirmative. The clinicaltrials.gov website attests that this medical trial is presently seeking participants, having been initially posted on November 25th 2020 and amended most recently on February 9th 2022 . 390 individuals need to be recruited from one facility for the study."

Answered by AI
~167 spots leftby Oct 2026