T82.7
Conditions
Interventions
Group 1: Rehabilitation and home care:
Standard dressing changes twice weekly performed by specialized wound care experts or by the patient/family
without CAP application.
Group 2: Rehabilitation and home care:
Twice-weekly standard dressing changes performed by specialized wound care experts or by the patient/family, supplemented by the applica
Sponsors
Herz- und Diabeteszentrum NRW, Klinik für Thorax- u. Kardiovaskularchirurgie, Universitätsklinik (Ruhr-Universität Bochum), Med. Fakultät OWL (Universität Bielefeld)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent available; assurance of proper application and participation in the study / family support; assurance of care provided by wound care specialists.
Exclusion criteria
Exclusion criteria: Pregnancy; patients with psychiatric or neurological disorders associated with impaired legal capacity; discharge to a nursing home, as continuous treatment cannot be ensured due to potential lack of self-care and changing caregiving personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First occurrence of a clinically diagnosed driveline infection (DLI) with a severity grade >2 according to the Destine classification within 12 months after LVAD implantation. The diagnosis is established based on standardized clinical, microbiological, and laboratory findings obtained during routine follow-up care and documented dressing changes. Treatment is indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality All-cause mortality within 12 months after LVAD implantation (yes/no; time to event in days). 2. Heart transplantation Occurrence of heart transplantation within 12 months after LVAD implantation (yes/no; time to event). 3. LVAD weaning Explantation of the LVAD system due to cardiac recovery within 12 months after implantation. | — |
Countries
Germany
Contacts
Public ContactVolker Lauenroth
Herz- und Diabeteszentrum NRW, Klinik für Thorax- u. Kardiovaskularchirurgie, Universitätsklinik (Ruhr-Universität Bochum), Med. Fakultät OWL (Universität Bielefeld)
Outcome results
None listed