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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1 and 2 post procedure

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

End of surgery pocket swab culture positivity

Secondary study objectives

CIED infection, defined as in the recent PADIT trial

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met