T81.0 T81.4 I89.8
Conditions
Interventions
Group 1: Usage of 10 g 4DryField® PH for hemostasis during the surgery.
Group 2: Usage of a 35 cm strip Tabotamp® for hemostasis during the surgery.
Sponsors
PlantTec Medical GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written consent to take part in the study, planned radical prostatectomy surgery (open as well as laparoscopic)
Exclusion criteria
Exclusion criteria: Known intolerance of starch or starch containing substances, existence of a clotting disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are two primary endpoints: the time (in minutes) until hemostasis is reached and the total drainage volume until the drainage is removed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the frequency of blood donations (as well as the respective mean total volume per patient) until discharge, the course of the hemoglobin and hematocrit concentrations within the first five days after surgery (this will only be evaluated for the patients which did not receive a blood donation because there values would be influenced by this), the frequency of the necessity to use additional electrocautery for hemostasis as well as the frequency of the following surgery-depending complications until the end of the study: anastomotic insufficiency, wound healing disturbances, infections, seromas, lymphoceles and hematomas. | — |
Countries
Germany
Contacts
Public ContactAndrea Pohl
Vivantes Klinikum am Urban
Outcome results
None listed