A Silver Lining in the VAD Sky

NCT ID: NCT05163392

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-06-30

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

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.

Conditions

LVAD (Left Ventricular Assist Device) Driveline Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Silverlon

Intervention Type: DEVICE

SIlver-plated biopatch

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

Tegaderm without biopatch

Interventions

Silverlon

SIlver-plated biopatch

Intervention Type: DEVICE

Control

Tegaderm without biopatch

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Consortium of Circulatory Assist Clinicians

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liviu Klein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Parnassus

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28781010 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33963835 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

21-35805

Identifier Type: -

Identifier Source: org_study_id