A Silver Lining in the VAD Sky

LVAD (Left Ventricular Assist Device) Driveline Infection Clinical Trial

— LVAD-SilverD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163392
• Other study ID #: 21-35805
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Sylvie Baudart, MS
• Phone: 415-203-4027
• Email: Sylvie.baudart[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• LVAD (Left Ventricular Assist Device) Driveline Infection

Intervention

Device:
• Silverlon
SIlver-plated biopatch
• Control
Tegaderm without biopatch

Locations

Country	Name	City	State
United States	UCSF Parnassus	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	International Consortium of Circulatory Assist Clinicians

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driveline infection	rate of driveline infection per 100 patient	1 year
Secondary	Allergies	rate of contact dermatitis per 100 patient	1 year
Secondary	Speciation	rate of bacterial species cultured per 100 patient	1 year
Secondary	Comfort	Rate of reported comfort level per 100 patient	1 year