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

A Silver Lining in the VAD Sky: Impact of Silver Dressing on LVAD Associated Driveline Infection

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

Study Overview

• Status: Recruiting
• Conditions: LVAD (Left Ventricular Assist Device) Driveline Infection
• Intervention / Treatment: Device: Silverlon; Device: Control

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, 2023. The initial follow-up period will be closed on December 31st 2023 with a continuation of the follow-up until December 31st 2024. 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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie Baudart, MS; Phone Number: 415-203-4027; Email: Sylvie.baudart@ucsf.edu
• Study Contact Backup: Name: Liviu Klein, MD; Email: liviu.klein@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Parnassus
      • Contact: Liviu Klien, MD, MS; Email: liviu.klein@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SilverD; 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.	Device: Silverlon; SIlver-plated biopatch
Active Comparator: ControlD; 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.	Device: Control; Tegaderm without biopatch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driveline infection	rate of driveline infection per 100 patient	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergies	rate of contact dermatitis per 100 patient	1 year
Speciation	rate of bacterial species cultured per 100 patient	1 year
Comfort	Rate of reported comfort level per 100 patient	1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: International Consortium of Circulatory Assist Clinicians
• Investigators: Principal Investigator: Liviu Klein, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Kusne S, Mooney M, Danziger-Isakov L, Kaan A, Lund LH, Lyster H, Wieselthaler G, Aslam S, Cagliostro B, Chen J, Combs P, Cochrane A, Conway J, Cowger J, Frigerio M, Gellatly R, Grossi P, Gustafsson F, Hannan M, Lorts A, Martin S, Pinney S, Silveira FP, Schubert S, Schueler S, Strueber M, Uriel N, Wrightson N, Zabner R, Huprikar S. An ISHLT consensus document for prevention and management strategies for mechanical circulatory support infection. J Heart Lung Transplant. 2017 Oct;36(10):1137-1153. doi: 10.1016/j.healun.2017.06.007. Epub 2017 Jun 23. No abstract available.
• Koken ZO, Yalcin YC, van Netten D, de Bakker CC, van der Graaf M, Kervan U, Verkaik NJ, Caliskan K. Driveline exit-site care protocols in patients with left ventricular assist devices: a systematic review. Eur J Cardiothorac Surg. 2021 Sep 11;60(3):506-515. doi: 10.1093/ejcts/ezab195.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 21-35805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers. Only aggregate data might be shared.

Drug and device information, study documents

• 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