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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
LVAD-SilverD Trial Summary
This trial will test a new protocol for managing drivelines, which are tubes that go from an external pump to an internal device. The new protocol includes a silver-based dressing and a new dressing change protocol. The goal is to reduce the risk of dermatitis and allergies.
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.Check my eligibility
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.See study design
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.
LVAD-SilverD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Driveline infection
Secondary outcome measures
Allergies
Comfort
Speciation
Side effects data
From 2022 Phase 1 trial • 31 Patients • NCT042387283%
open area in inframammary fold
100%
80%
60%
40%
20%
0%
Study treatment Arm
Silverlon Arm
LVAD-SilverD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SilverDExperimental Treatment1 Intervention
The SIlverD arm includes:
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.
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:
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.
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
Find a Location
Who is running the clinical trial?
International Consortium of Circulatory Assist CliniciansOTHER
1 Previous Clinical Trials
150 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,535 Total Patients Enrolled
Liviu Klein, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
694 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.
Research Study Groups:
This trial has the following groups:- Group 1: SilverD
- Group 2: ControlD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolment into this experiment open to participants yet?
"Affirmative, the clinicaltrials.gov website displays this trial is presently seeking volunteers. Initially posted on February 1st 2022, there have been recent updates made to the study as of March 22nd 2022. The research team intends to recruit 20 people from a single medical centre for the experiment."
Answered by AI
How many participants are the investigators aiming to recruit for this experiment?
"Affirmative. The information available on clinicaltrials.gov demonstrates that this medical investigation, which was first announced on February 1st 2022, is actively recruiting volunteers. A total of 20 participants are required at a single location."
Answered by AI
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