Barrier Dressing for Infections

Overseen By Alper Aydin, Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Iodine allergy, Active device infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

390 Participants Needed

Trial Summary

What is the purpose of this 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Barrier dressing for infections?

Research shows that bacterial barrier dressings, which are similar to the Barrier dressing, are effective in preventing wound infections by limiting bacterial growth. These dressings often contain antimicrobial agents like silver ions, which help protect wounds from infection without releasing harmful substances. ^{1 2 3 4 5}

Is the barrier dressing safe for use in humans?

Some bacterial barrier dressings can release toxic chemicals that may harm wound cells, but a new type of dressing has been developed to avoid this issue. This new dressing is designed to absorb wound fluids without releasing harmful substances, suggesting it may be safer for human use. ^{1 2 6 7 8}

How is the Barrier Dressing for Infections treatment different from other treatments for wound infections?

This novel bacterial barrier dressing is unique because it absorbs wound fluid without releasing toxic chemicals, unlike traditional dressings that use microbicidal agents like silver or iodine, which can harm wound cells and promote bacterial resistance. ^{1 2 6 9 10}

Research Team

Alper Aydin, Dr.

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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.

Inclusion Criteria

PADIT risk score ≥ 5

I have had previous surgery to adjust or change an implanted device.

Exclusion Criteria

Unable or unwilling to provide informed consent

De novo device implantation

Active device infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a procedure with either an experimental or control application of an iodine-infused barrier dressing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pocket swab culture positivity and potential CIED infections

1 month

Extended Follow-up

Participants are monitored for CIED infections, including pocket infections, endocarditis, and bloodstream infections

2 years

Treatment Details

Interventions

• Barrier dressing

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Microbial barriers. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of antimicrobial efficacy and biocompatibility of a novel bacterial barrier dressing. [2015]

3. England pubmed.ncbi.nlm.nih.gov

A real-life clinical evaluation of a next-generation antimicrobial dressing on acute and chronic wounds. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Battling bacteria in wound care. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Infected wound management: advanced technologies, moisture-retentive dressings, and die-hard methods. [2019]

6. Poland pubmed.ncbi.nlm.nih.gov

Preparation and characterization of poly(ethylene oxide)/zinc oxide nanofibrous scaffold for chronic wound healing applications. [2021]

7. England pubmed.ncbi.nlm.nih.gov

An evaluation of the skin stripping of wound dressing adhesives. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Dressings and wound infection. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Wound dressings from a hygienic point of view using the example of sorbion sachet S. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Choosing an appropriate antibacterial dressing. [2013]