N/A
Completed N=25
A Silver Lining in the VAD Sky
LVAD (Left Ventricular Assist Device) Driveline Infection
Source: ClinicalTrials.gov NCT05163392 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Driveline Infection Rate — 0.51; 06.28 infections per 100 patient-month
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Driveline Infection Rate |
0.51; 06.28 | — |
| SECONDARY Time to First Driveline Infection |
458; 232 | — |
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
Data sourced from ClinicalTrials.gov (NCT05163392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.