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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an iodine-infused barrier dressing to determine its effectiveness in reducing infections during procedures involving heart devices. The study examines how well this dressing prevents contamination during device implantation or upgrades. Participants will be randomly assigned to one of two groups: one receives the dressing before the incision, and the other before the culture swab. Individuals who have previously undergone a heart device procedure and require a lead or battery change might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially improve outcomes for future patients.

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 prior data suggests that this barrier dressing is safe for preventing infections?

Research has shown that barrier dressings, such as the iodine-infused one in this study, are generally safe for people. A review of several studies found that new types of dressings can reduce the risk of infections after surgery, indicating they are well-tolerated by patients.

While no specific study has proven that one type of dressing is the best at preventing infections, modern dressings, including iodine-infused ones, have been associated with better safety results. Therefore, they appear to be a safe choice for many people.

However, this study aims to further investigate the safety and effectiveness of these dressings in preventing infections during procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the barrier dressing approach because it incorporates an adhesive iodine-infused dressing, which offers a dual-action defense against infections. Unlike standard care that applies this dressing post-procedure, the new method involves using it before the incision, potentially enhancing infection control from the start. This proactive application could lead to fewer complications and faster recovery times, setting it apart from traditional post-procedure methods.

What evidence suggests that this barrier dressing is effective for preventing infections?

This trial will compare the effectiveness of iodine-infused barrier dressings in preventing infections. Research has shown that special dressings with iodine can help reduce infections during surgeries. One study found that these dressings lowered the chance of infections in heart device surgeries. Another study demonstrated that these advanced dressings significantly reduced the risk of infections in stomach and intestine surgeries. Additionally, iodine-infused dressings may save money by reducing infection rates. Overall, these dressings appear promising in preventing infections during medical procedures. ^{6 7 8 9 10}

Who Is on the Research Team?

Alper Aydin, Dr.

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693728/

Effectiveness of iodine-impregnated incise drapes for ... Using iodine-impregnated drapes in cardiac surgery patients may effectively reduce infections and provide cost-savings, but further research is required.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080198/

Effectiveness of advanced dressings in preventing surgical ... We found that the use of advanced dressings for primary wounds in gastrointestinal surgery was associated with a significantly lower risk of SSI than that ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266650182300332X

Adherent skin barrier drape use is associated with a ... Our study results suggest that the use of an adherent skin barrier during the index procedure may reduce the risk of cardiac device infection.

4. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-02809-9

Role of wound protectors in preventing surgical site infection ... The results showed that the application of WPs during abdominal surgery could significantly reduce the SSI rate (RR = 0.63, 95% CI: 0.50–0.80, P ...

5. tandfonline.com tandfonline.com/doi/full/10.3111/13696998.2010.502077

a strategy for the reduction of surgical site infections An antimicrobial barrier dressing strategy is cost neutral if the incidence of infection is reduced by at least 9% compared with a post-operative film dressing.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464019/

Dressings for the prevention of surgical site infection - PMC We found no clear evidence to suggest that one dressing type was better than any other at reducing the risk of surgical site infection, nor that covering wounds ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04591366

Study Details | NCT04591366 | Barrier-Protect Study This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655079/

Evaluating and Improving Surgical Site Infection Prevention Patient data. This table shows outcomes in terms of surgical site infection (SSI) rate, timely use of surgical antibiotic prophylaxis (SAP) ...

9. researchgate.net researchgate.net/publication/47755951_Barrier_dressings_in_surgical_site_infection_prevention_strategies

Barrier dressings in surgical site infection prevention ... »: Modern dressings have the potential to yield better safety outcomes and increased patient satisfaction; however, there is a paucity of ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1743919120306142

Evaluation of different surgical dressings in reducing ... The results of the direct meta-analysis revealed that novel dressings significantly reduced the overall SSI rate with an OR of 1.026 (95% CI: 1.013–1.040, p < ...