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A Silver Lining in the VAD Sky (LVAD-SilverD)

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ClinicalTrials.gov Identifier: NCT05163392
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
International Consortium of Circulatory Assist Clinicians
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The investigators propose to conduct a prospective randomized trail (RCT) of a driveline management protocol. The study will be initiated at UCSF from January 1st 2022 to December 31st 2022 as a pilot to be extended to other sites with the ultimate goal to develop a multi-center RCT. The driveline dressing protocol studied will include a silver-based dressing barrier as well as a dressing change protocol and material designed to reduce the risk of driveline dressing induced dermatitis and allergies. Assessment will include DLI rates, DLI speciation, dermatitis rate, comfort, ease of use, compliance and cost

Condition or disease Intervention/treatment Phase
LVAD (Left Ventricular Assist Device) Driveline Infection Device: Silverlon Device: Control Not Applicable

Detailed Description:

This prospective research clinical trial will be conducted in a single academic medical center. The enrollment period will be between January 1st, 2022 and December 31st, 2022. The initial follow-up period will be closed on December 31st 2022 with a continuation of the follow-up until December 31st 2023. Patients will be selected from current LVAD patients followed by our medical center clinic and from patients implanted with LVAD at our center during the study enrollment timeframe. Patients will be randomly assigned to the control protocol and the silver protocol. Both protocols will be taught to the patients and nursing staff by the VAD coordinators. The comparative evaluation will be done through adverse event collection, driveline culture results, patient survey and DL photos at specific intervals.

A. Inclusion Criteria

The following patients will be included in the study:

  • >18 years of age
  • Implanted with LVAD as DT or BTT at the Academic Medical Center with implantation scheduled between January 1st, 2022 and December 31st, 2022
  • Implanted prior to January 1st 2022 with no history or signs and symptoms of DLI as of January 1st 2022.

B. Exclusion criteria The following will be excluded from the study. Patients with

  • A history of DLI
  • A history of sternal wound infection
  • Implantation secondary to VAD exchange for device infection C. Interventions A new driveline dressing kit will be trialed on patients randomized to the intervention arm of the study. Both arms will have a regular dressing kit and a sensitive dressing kit.

The trial arm kits include:

  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.

The control arm kits include:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomly assigned to one of 2 arms conducted in parallel.

The trial arm kits include:

  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.

The control arm kits include:

  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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Silver Lining in the VAD Sky: Impact of Silver Dressing on LVAD Associated Driveline Infection
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: SilverD

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.
Device: Silverlon
SIlver-plated biopatch

Active Comparator: ControlD

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.
Device: Control
Tegaderm without biopatch




Primary Outcome Measures :
  1. Driveline infection [ Time Frame: 1 year ]
    rate of driveline infection per 100 patient


Secondary Outcome Measures :
  1. Allergies [ Time Frame: 1 year ]
    rate of contact dermatitis per 100 patient

  2. Speciation [ Time Frame: 1 year ]
    rate of bacterial species cultured per 100 patient

  3. Comfort [ Time Frame: 1 year ]
    Rate of reported comfort level per 100 patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >18 years of age
  • 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:

  • A history of DLI
  • A history of sternal wound infection
  • Implantation secondary to VAD exchange for device infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163392


Contacts
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Contact: Sylvie Baudart, MS 415-203-4027 Sylvie.baudart@ucsf.edu
Contact: Liviu Klein, MD liviu.klein@ucsf.edu

Locations
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United States, California
UCSF Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Liviu Klien, MD, MS       liviu.klein@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
International Consortium of Circulatory Assist Clinicians
Investigators
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Principal Investigator: Liviu Klein, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05163392    
Other Study ID Numbers: 21-35805
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers. Only aggregate data might be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infections