Silver-Based Dressing for LVAD Infection

(LVAD-SilverD Trial)

Overseen By Liviu Klein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: DLI, Sternal wound infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new silver-based dressing to determine its effectiveness in preventing infections in individuals with a Left Ventricular Assist Device (LVAD), a heart pump. The goal is to assess whether this special dressing can lower infection rates and reduce skin irritation compared to standard dressings. Participants will use either the silver-based dressing (Silverlon) or the standard dressing, with evaluations on comfort and ease of use. Individuals who have recently received an LVAD and do not have a history of certain infections may be suitable for this trial. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance post-surgical care for future LVAD patients.

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

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

What prior data suggests that this driveline management protocol is safe?

Studies have shown that silver-based dressings, such as Silverlon, are generally safe for use. Research indicates that silver does not harm healthy skin but instead helps reduce infections at sites where medical devices attach to the body. This is particularly beneficial for individuals using devices like the Left Ventricular Assist Device (LVAD), which aids the heart in pumping blood.

Specifically, using Silverlon significantly reduced infections at these connection points, lowering the risk of bacterial infections.

Overall, silver-based dressings are well-tolerated, with no major safety concerns reported in the studies. They could be a useful option for preventing infections in those who need them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this silver-based dressing because it offers a unique antimicrobial barrier for LVAD infections. Unlike standard options that lack an antimicrobial layer, this dressing uses Silverlon, known for its ability to reduce bacterial growth. The inclusion of silver not only provides a strong barrier against infection but also aims to extend the time between dressing changes, potentially improving patient comfort and reducing the risk of infection. This innovative approach could significantly enhance the management of LVAD-related infections.

What evidence suggests that this driveline management protocol is effective for LVAD infection?

Research shows that silver-based dressings, such as Silverlon, effectively prevent infections, particularly in patients with Left Ventricular Assist Devices (LVADs). In this trial, participants in the SilverD arm will use a Silverlon antimicrobial patch as part of their dressing regimen. Studies have found that Silverlon significantly reduces infections in the bloodstream and around LVAD wires. The silver in these dressings kills germs and keeps the area clean, lowering the risk of infection. In some cases, no infections occurred with silver-based dressings, compared to a 13% infection rate in those not using them. This evidence suggests that Silverlon is a strong option for reducing infection risk and skin problems in LVAD patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Liviu Klein, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a Left Ventricular Assist Device (LVAD) implanted as either destination therapy or bridge to transplant at the Academic Medical Center within the specified dates. It's not for those with previous device infections or sternal wound infections.

Inclusion Criteria

Implanted with LVAD as DT or BTT at the Academic Medical Center with implantation scheduled between January 1st, 2022 and December 31st, 2022

Exclusion Criteria

You have received donor lymphocyte infusion (DLI) in the past.

You have had an infection in the chest area where the breastbone is located in the past.

You have had a previous surgery to replace a heart device due to an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the SilverD or ControlD arm, with driveline dressing changes and monitoring for infection rates.

104 weeks

Weekly visits for dressing changes

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued assessment of driveline infection rates.

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Silver-based dressing barrier
• Silverlon

Trial Overview The study tests a new driveline dressing protocol using Silverlon, a silver-based barrier, aimed at reducing infection and skin issues in LVAD patients. This pilot RCT will evaluate infection rates, skin reactions, comfort, ease of use, adherence to the protocol and cost-effectiveness.

How Is the Trial Designed?

Group I: SilverD Experimental Treatment 1 Intervention

The SIlverD arm includes: 1. For standard dressing: a silverlon antimicrobial patch, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be weekly. 2. For sensitive skin dressing: a silverlon antimicrobial patch, Providone/iodine swabs for cleaning, an occlusive dressing with window, and sensitive driveline anchors. The driveline dressing change frequency will be weekly.

Group II: ControlD Active Control 1 Intervention

The ControlD arm includes: 1. For standard dressing: No antimicrobial barrier, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96 hours. 2. For sensitive skin dressing: No antimicrobial barrier, Providone/iodine swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96hr.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

International Consortium of Circulatory Assist Clinicians

Collaborator

Trials

3

Recruited

200+

International Consortium of Circulatory Assist Clinicians

Collaborator

Trials

1

Recruited

20+

Citations

1. jhltonline.org jhltonline.org/article/S1053-2498(25)00760-0/pdf

LVAD Driveline Infection Prevention Several studies propose that use of silver-based dressing is beneficial in preventing DLI. Silverlon is a silver impregnated dressing which contains more than ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053249823016418

A Weapon Against Driveline Infections in Lvad Patients A treatment regime involving the use of Silverlon on drivelines has demonstrated significant reduction of driveline related bloodstream and pocket infections.

3. silverlon.com silverlon.com/global/resources/clinical-studies

Clinical Studies | Silver Dressings | Silverlon Global Multiple, peer-reviewed, published studies have shown the effect that Silverlon can have. Studies in a wide variety of Surgical, Wound and Burn Care ...

4. withpower.com withpower.com/trial/silver-based-dressing-for-lvad-infection-cfb4e

Silver-Based Dressing for LVAD Infection ... This trial is testing a new bandage with a silver patch to prevent infections and skin problems. The silver helps kill germs, aiming to keep the area clean.

5. bravidamedical.com bravidamedical.com/wp-content/uploads/2025/04/Silver-BasedDressingsForTheReductionOfSurgicalSiteInfection.pdf

Silver-based dressings for the reduction of surgical site ... There were no infections reported, compared to a 13% infection rate in 39 historical controls from the same institution treated identi- cally (except for the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8434872/

Driveline exit-site care protocols in patients with left ventricular ... Therefore, the use of a silver-based dressing only in the first 6 months after LVAD implantation may be (cost) effective in preventing driveline ...

7. bravidamedical.com bravidamedical.com/int/clinical-studies/

Clinical Studies – Infection Prevention and Wound Care ... Efficacy of Silver Plated Dressing Pad in Reducing Left Ventricular Assist Device Driveline Infections When Compared to Chlorhexidine Impregnated Disc. February ...

8. irl.umsl.edu irl.umsl.edu/cgi/viewcontent.cgi?article=2288&context=dissertation

Left Ventricular Assist Device (LVAD) Driveline Infection ... A confidence interval of 95% was used. Results: A bi-weekly dressing change protocol using a pre-packaged kit, clear occlusive dressing, silver-impregnated ring ...