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Can a sticky shield stop heart device infections?

NCT ID NCT04591366

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an iodine-coated barrier dressing applied before surgery can reduce bacteria around heart devices like pacemakers. About 390 adults having a device replacement or upgrade are randomly assigned to get the dressing before or after the incision. Researchers then swab the pocket to see if the dressing cuts contamination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iodine impregnated barrier dressing
What this could lead to
If it works, this could point toward a simple way to lower infection rates in heart device surgeries.
What could go wrong
This is a small pilot study, not a large definitive trial. The main outcome is a lab swab, not actual infection rates, so results may not translate to fewer infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

390 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Infections infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infection

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

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