Active not recruitingNAINTERVENTIONAL

Barrier-Protect Study

The Barrier-Protect Study is investigating a special sterile dressing that contains iodine. Its main goal is to see if using this dressing can help prevent infections after operations to change or upgrade heart devices like pacemakers or defibrillators. Infections can be a serious problem, so finding ways to reduce them is important. We believe that keeping the area around the device clean during surgery could make a big difference. This study will compare putting the dressing on early in the procedure with putting it on later, just before taking a swab for testing. Patients and some staff involved won't know which method is being used, to ensure fair results.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

390

Start

25 Nov 2020

Estimated completion

15 Oct 2027

Infection

What is this study about?

When people have operations to change or upgrade their heart devices, like pacemakers or defibrillators, there's a small chance of getting an infection. These infections can be serious, so doctors are always looking for better ways to prevent them. One idea is to make sure the area where the device is put (called the 'pocket') stays as clean as possible during the whole operation.

This study, called the Barrier-Protect Study, is looking into a special protective dressing that has iodine in it. Iodine is known to kill germs. The main question we want to answer is: does putting this special dressing on *earlier* during the operation help reduce the chance of germs getting into the wound, compared to putting it on later? By reducing these germs, we hope to lower the risk of infection.

To find this out, some patients will have the dressing applied early, before any cut is made, while others will have it applied just before a swab sample is taken at the end of the procedure. Neither the patients nor some of the staff will know which method is being used. This helps make sure the study results are fair and reliable, so we can understand if this dressing truly makes a difference in preventing infections.

Key takeaways

Tests a special iodine dressing to prevent infections.
For people having second or later heart device operations.
Compares putting the dressing on early vs. late.
You won't know which method is used, for fair results.
Aims to reduce the risk of infection after surgery.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. Importantly, this study is for people who are having a *second or later* operation on their heart device pocket, which means you've had a pacemaker or similar device before and are now having it changed, updated, or having a wire (lead) fixed.

We also look at a 'risk score' for infection. To be eligible, your personal risk score must be 5 or higher. This helps us focus on people who might benefit most from better infection prevention. You also need to be able to understand what the study involves and agree to take part.

However, you can't join if this is your very first heart device operation, if you currently have an infection around your device, if you are allergic to iodine, or if doctors believe your life expectancy is less than two years. All genders are welcome.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a pacemaker/defibrillator changed or fixed, not your first one?
Are you able to agree to take part (give informed consent)?
Do you *not* currently have an infection around your device?
Are you *not* allergic to iodine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study during your planned heart device operation. There are no extra hospital visits required beyond your usual care. During the operation, a special iodine dressing will be used. At the very end of the procedure, a swab will be taken from the device pocket to check for any germs. You won't know if the dressing was put on early or just before the swab, and neither will the nurse taking samples. After your operation, your doctors will follow your recovery as normal, and the study will look at your medical records to see if you develop any infections over time. The total duration of your direct involvement in the study procedures is just during your operation.

Potential risks and benefits

Taking part in this study might offer a potential benefit by potentially reducing your risk of infection after your heart device procedure, though we don't know for sure if the early application of the dressing will have this effect. There are no known additional risks to you beyond the standard risks of your planned surgery, as the dressing is already approved for use. However, like all medical studies, there are no guarantees of direct benefit. You are free to choose not to participate or to withdraw from the study at any time, even if you’ve already agreed, without affecting your medical care.

Locations (1)

University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada

Common questions

What kind of dressing is this?

It's a special sterile dressing that contains iodine, which is used to kill germs.

Will I know if I'm getting the 'early' dressing or the 'late' dressing?

No, you won't know, and neither will some of the staff, to make sure the results are fair.

Will this study give me any extra treatments or medicines?

No, the study only involves the timing of applying a special dressing during your planned operation. There are no additional medicines.

How long will I be in this study?

Your direct involvement in the study procedures happens during your operation. The study will then collect information from your medical records over time.

What if I decide I don't want to be in the study after I've agreed?

You are free to withdraw from the study at any time without it affecting your medical care.