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| Name | Class |
|---|---|
| International Consortium of Circulatory Assist Clinicians | OTHER |
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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
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:
The control arm kits include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SilverD | Experimental | The SIlverD arm includes:
|
|
| ControlD | Active Comparator | The ControlD arm includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silverlon | Device | SIlver-plated biopatch |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Driveline Infection Rate | Number of driveline infection per 100 patient-months | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Driveline Infection | Number of days to first driveline infection | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liviu Klein, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Parnassus | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28781010 | Background | 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. | |
| 33963835 |
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No IPD will be shared with other researchers. Only aggregate data might be shared.
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25 patients were enrolled and all met inclusion criteria and were randomized to treatment or placebo
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| ID | Title | Description |
|---|---|---|
| FG000 | SilverD | The SIlverD arm includes:
Silverlon: SIlver-plated biopatch |
| FG001 | ControlD | The ControlD arm includes:
Control: Tegaderm without biopatch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SilverD | The SIlverD arm includes:
Silverlon: SIlver-plated biopatch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Driveline Infection Rate | Number of driveline infection per 100 patient-months | Posted | Number | infections per 100 patient-month | 2 year |
|
Adverse events data were collected for 1 year
5 patients died due to heart failure. Cause of death was unrelated to the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SilverD | The SIlverD arm includes:
Silverlon: SIlver-plated biopatch |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Baudart | UCSF | 415-203-4027 | sylvie.baudart@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 1, 2025 | Apr 17, 2025 | Prot_SAP_ICF_003.pdf |
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Patients will be randomly assigned to one of 2 arms conducted in parallel.
The trial arm kits include:
The control arm kits include:
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| Device |
Tegaderm without biopatch |
|
| Background |
| 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. |
| BG001 | ControlD | The ControlD arm includes:
Control: Tegaderm without biopatch |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
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|
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| Secondary | Time to First Driveline Infection | Number of days to first driveline infection | Posted | Mean | 95% Confidence Interval | days | 2 year |
|
|
|
| 3 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | ControlD | The ControlD arm includes:
Control: Tegaderm without biopatch | 2 | 11 | 0 | 11 | 0 | 11 |
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