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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Silver has been used in wound care to reduce bacteria and promote healing since 1968.

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 data supports the effectiveness of the treatment Silverlon for LVAD infection?

Silverlon, a silver-based dressing, has shown antibacterial properties and is used to prevent infections in surgical sites, such as those following colon and rectal surgery. Its effectiveness is supported by its broad-spectrum antibiotic properties, which are effective against multidrug-resistant bacteria, as demonstrated in studies involving wound healing and infection prevention. ^{1 2 3 4 5}

Is the silver-based dressing generally safe for use in humans?

Research suggests that silver-based dressings, like Silverlon, are generally safe for use in humans. Studies show that silver does not adversely affect viable cells and does not lead to significant silver absorption into the body, indicating low risk of toxicity. ^{1 3 5 6 7}

How does the Silverlon treatment differ from other treatments for LVAD infection?

Silverlon is unique because it uses a high concentration of silver, which has antiseptic and anti-inflammatory properties, to prevent infections. Unlike standard antibiotic treatments, Silverlon acts as a barrier to infection and is specifically designed to prevent surgical site infections, making it potentially more effective against antibiotic-resistant bacteria. ^{1 3 6 8 9}

Research Team

Liviu Klein, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Evaluation of silver-containing activated carbon fiber for wound healing study: In vitro and in vivo. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of two absorbent silver dressings in a porcine partial-thickness excisional wound model. [2018]

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

The use of silver nylon in preventing surgical site infections following colon and rectal surgery. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical and in vitro performance of an antibiofilm Hydrofiber wound dressing. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating antimicrobial efficacy of new commercially available silver dressings. [2021]

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

A discussion of silver as an antimicrobial agent: alleviating the confusion. [2016]

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

Assessment of Silver Levels in a Closed-Incision Negative Pressure Therapy Dressing: In Vitro and In Vivo Study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Early host tissue response to different types of vascular prostheses coated with silver acetate or vaporized metallic silver. [2014]

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

Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? [2022]