T81.0 T82.1
Conditions
Interventions
Group 1: 1. Control group:
Standard post operative management
a) put on tape with compression underneath that stays until next day
b) put on sand sack on compression bandage within first 12 to 24 hou
Sponsors
Medizinische Klinik m. S. Kardiologie Rhythmologie-Elektrophysiologie und Devicetherapie; Charité Campus Virchow Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: -Planned primary implenation of pacemaker or ICD. -Therapy with at least one antiplatelet or an oral anticoagulant - -Age over 18 years -Capacity to consent -Existence of a written informed consent form
Exclusion criteria
Exclusion criteria: -Clear idication for one of the possible prodcedere -Pregnancy -Legally in medical matters supervised patients -Participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of clinical relevant hematoma are defined by a hematoma-score: - size >20x20cm and decrease of hemoglobin >2 points - palpable mass of hematoma, min. 2 cm - prolongation of hospital stay - pocket infection caused by existing hematoma - reoperation required due to hematoma - running anticoagulation has to be reduced or paused The occurrrence of clinical relevant hematoma will be checked on a) the first postoperative day and b) between the 11.-15. postoperative day. c) after 6 weeks final follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome such as displacement of materials, pocket infections and prolonged wound healing will be mesured by their typically clinical appereance the first day postoperative and between the 11.-15. day after surgery. | — |
Countries
Germany
Contacts
Public ContactPhilipp Attanasio
Medizinische Klinik m. S. Kardiologie Rhythmologie-Elektrophysiologie und Devicetherapie; Charité Campus Virchow Klinikum
Outcome results
None listed