What side effects are associated with this type of intervention?

Common treatments for Left Ventricular Assist Device (LVAD) infections include the use of antimicrobial dressings, such as silver-based dressings, and systemic antibiotics. Silver-based dressings are known for their antimicrobial properties, which help reduce infection rates. However, they can cause side effects such as local skin irritation, dermatitis, and potential allergic reactions. Systemic antibiotics, often used in conjunction with dressings, can lead to side effects including gastrointestinal disturbances, allergic reactions, and the development of antibiotic-resistant bacteria. It is essential to monitor patients for these side effects and adjust treatment protocols as necessary.

What prior FDA approvals exist?

The FDA has approved various antimicrobial treatments for managing infections associated with medical devices, including LVADs. Silver-based dressings, known for their antimicrobial properties, have been utilized to reduce infection rates in such settings. These dressings work by releasing silver ions, which have broad-spectrum antimicrobial activity. While specific FDA approvals for LVAD infections are not detailed, the use of silver-based dressings aligns with broader strategies to prevent device-related infections by providing a barrier to microbial colonization and growth.

What other types of research exist?

Promising alternatives to silver-based dressing barriers for LVAD infection patients include chlorhexidine-impregnated dressings and antibiotic-coated materials, such as those coated with dicloxacillin or clindamycin. These alternatives have demonstrated efficacy in preventing bacterial colonization and infection in various medical settings.

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Procedure

Silver-Based Dressing for LVAD Infection (LVAD-SilverD Trial)

N/A

Recruiting

Led By Liviu Klein, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions due to the silver in Silverlon dressings. However, part of this study's purpose is to assess if these dressings actually decrease such dermatitis incidents.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Driveline infection

Secondary study objectives

Allergies

Comfort

Speciation

Side effects data

From 2022 Phase 1 trial • 31 Patients • NCT04238728

open area in inframammary fold

100%

80%

60%

40%

20%

Study treatment Arm

Silverlon Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SilverDExperimental Treatment1 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: ControlDActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silverlon

2020

Completed Phase 1

~160

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Left Ventricular Assist Device (LVAD) infections, such as silver-based dressing barriers, utilize antimicrobial properties to reduce infection rates. Silver ions released from these dressings disrupt bacterial cell membranes, interfere with enzyme function, and inhibit DNA replication, thereby reducing bacterial colonization and infection. This is particularly important for LVAD patients as it helps prevent severe complications like sepsis and device failure, ultimately improving patient outcomes and the longevity of the device.

Oxacillin plus ertapenem rapidly clears persistent left ventricular assist device-related methicillin-susceptible Staphylococcus aureus bacteremia.Secondary prevention of coronary artery disease with antimicrobials: current status and future directions.