InfectionNCT04591366
Barrier-Protect Study
A study testing Barrier dressing in people with Infection, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Barrier dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2020to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- PADIT risk score ≥ 5
Who cannot join
- Unable or unwilling to provide informed consent.
- De novo device implantation.
- Active device infection.
- Iodine allergy
- Life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
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.
- Conditions
- Infection
- Being tested
- Barrier dressing
- Keywords
- Cardiac, Device
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrier dressingOther
A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Other: Barrier dressing |
| Intervention | Experimental | 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. Receives: Other: Barrier dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of surgery pocket swab culture positivity
To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection
Measured: one month post procedure
Secondary outcomes (1)
CIED infection, defined as in the recent PADIT trial
- 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)
Measured: Year 1 and 2 post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Nov 2020
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alper Aydin, Dr., Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591366
- Sponsor's protocol ID
- 20200369-01H
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin A, Golian M, Klein A, Redpath C, Davis DR, Ramirez FD, Nair GM, Green MS, Sadek M, Nery PB, Hansom SP, Al Hinai G, Weng W, Berbenetz N, Thibert MJ, Salmeen Y, Martow E, Tan LW, Almidani G, Alshehri A, Alzahrani A, Alharbi F, Corrales-Medina V, Wells GA, Birnie DH. Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1016-1023. doi: 10.1001/jamacardio.2025.2835.
PubMed 40864462
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04591366
- Acronym / sponsor ID
- 20200369-01H
- Conditions
- Infection
- Keywords
- Cardiac, Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Barrier dressingStandard 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. |
| Intervention | Experimental | Other: Barrier dressingStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- PADIT risk score ≥ 5
Key exclusion criteria (5 listed)
- Unable or unwilling to provide informed consent.
- De novo device implantation.
- Active device infection.
- Iodine allergy
- Life expectancy less than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barrier dressingA barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision. | Other | Control, Intervention |
Primary outcome
End of surgery pocket swab culture positivity
Time frame: one month post procedure
To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection
1 secondary outcome
CIED infection, defined as in the recent PADIT trial
Time frame: Year 1 and 2 post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 40864462Aydin A, Golian M, Klein A, Redpath C, Davis DR, Ramirez FD, Nair GM, Green MS, Sadek M, Nery PB, Hansom SP, Al Hinai G, Weng W, Berbenetz N, Thibert MJ, Salmeen Y, Martow E, Tan LW, Almidani G, Alshehri A, Alzahrani A, Alharbi F, Corrales-Medina V, Wells GA, Birnie DH. Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1016-1023. doi: 10.1001/jamacardio.2025.2835.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Aydin, Dr. principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrier dressing in people with Infection, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of surgery pocket swab culture positivity (time frame: one month post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.