Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Liviu Klein, MD
Headshot of Liviu Klein
Liviu Klein

Description

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

Official Title

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

Details

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.

Keywords

LVAD (Left Ventricular Assist Device) Driveline Infection, Infections, Silverlon, SilverD, ControlD

Eligibility

You can join if…

Open to people ages 18 years and up

  • >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

You CAN'T join if...

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

Location

  • UCSF Parnassus accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Liviu Klein, MD
    My clinical interests are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05163392
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated