UCSF Parnassus
San Francisco, California, 94143, United States
Completed
NCT Number: NCT05163392
A Silver Lining in the VAD Sky
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
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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:
- 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.
The control arm kits include:
- 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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Silverlon
DeviceSIlver-plated biopatch
Control
DeviceTegaderm without biopatch
Primary outcomes
-
Driveline Infection Rate
Time frame: 2 year
Number of driveline infection per 100 patient-months
Secondary outcomes
-
Time to First Driveline Infection
Time frame: 2 year
Number of days to first driveline infection
Sponsors and collaborators
Lead sponsor
University of California, San Francisco
Other
Collaborators
- International Consortium of Circulatory Assist Clinicians
Registry information
Official study title
A Silver Lining in the VAD Sky: Impact of Silver Dressing on LVAD Associated Driveline Infection
Acronym: LVAD-SilverD
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2026
- First posted
- Dec 20, 2021
- Registry last updated
- Feb 13, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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