Lymphatic fistular
Conditions
Interventions
Group 1: Use of 4DryField®PH during surgery
Group 2: without using 4DryField®PH during surgery
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - The patient is at least 18 years old and at most 90 years old - Written documented informed consent and agreement to participate in the study - Patients who are able to follow study instructions and are likely to adhere to all required study visits (compliance) - Patients who are scheduled for axillary or inguinal lymph node dissection
Exclusion criteria
Exclusion criteria: - Patient is unable to understand the scope, significance, and consequences of this clinical trial - Known allergy to any of the components of the medical device - Known or ongoing abuse of medications, drugs, or alcohol - Lack of suitability of the patient to participate in the study as determined by the investigator - Active disseminated coagulation disorder - Patients with chronic lymphedema of the extremity to be operated on - Emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention time of the drainage (Removal of the redon drainage from a flow rate <40ml/24h without suction and without sonographic evidence of an obstruction; removal of the suction if the flow rate is reduced by 2/3 within 24h or if the flow rate is <50ml/24h) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Drainage volume - wound infections - Length of hospital stay - Repeat drain placement/puncture - Recording of days until continuation of system therapy | — |
Countries
Germany
Contacts
Public ContactAzin Jafari
Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und GefäßchirurgieUniversitätsklinikum Bonn
Outcome results
None listed