Study Summary
This trial will test a new protocol for managing drivelines, which are tubes that go from an external pump to an internal device. The new protocol includes a silver-based dressing and a new dressing change protocol. The goal is to reduce the risk of dermatitis and allergies.
Eligible Conditions
- Left Ventricular Assist Device Infection
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 1 year
1 year
Allergies
Comfort
Driveline infection
Speciation
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
ControlD
1 of 2
SilverD
1 of 2
Active Control
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: Silverlon · No Placebo Group · N/A
SilverD
Device
Experimental Group · 1 Intervention: Silverlon · Intervention Types: DeviceControlD
Device
ActiveComparator Group · 1 Intervention: Control · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silverlon
2020
Completed Phase 2
~160
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,280 Previous Clinical Trials
11,577,564 Total Patients Enrolled
International Consortium of Circulatory Assist CliniciansUNKNOWN
Liviu Klein, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
830 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are over 18 years of age.
References
- Koken, Zeliha Ozdemir, Yunus C Yalcin, Diana van Netten, Chantal C de Bakker, Maaike van der Graaf, Umit Kervan, Nelianne J Verkaik, and Kadir Caliskan. 2021. “Driveline Exit-site Care Protocols in Patients with Left Ventricular Assist Devices: A Systematic Review”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezab195.
- Kusne, Shimon, Martha Mooney, Lara Danziger-Isakov, Annemarie Kaan, Lars H. Lund, Haifa Lyster, Georg Wieselthaler, et al.. 2017. “An ISHLT Consensus Document for Prevention and Management Strategies for Mechanical Circulatory Support Infection”. The Journal of Heart and Lung Transplantation. Elsevier BV. doi:10.1016/j.healun.2017.06.007.
- 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.
- 2022. "A Silver Lining in the VAD Sky". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163392.
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Conditions
Cancer Related
Treatments