Table 1.
Flow Chart COBBANA Trial.
Visit 1 (Screening) | Visit 2 (OP) | Visit 3 (2 ± 1 days post OP) | Visit 4 (Day of discharge) | Visit 5 (30 ± 10 Days post OP) | |
Patient information | X | ||||
Informed consent | X | ||||
Demographic data* | X | ||||
Smoker/non-smoker | X | ||||
Inclusion/exclusion | X | ||||
Past medical history | X | ||||
Physical examination | X | X | X 1) | X 1) | X 1) |
Surgery | X | ||||
Time to obtain hemostasis | X | ||||
Deviation from surgical procedures as described in the protocol | X | ||||
Number of used devices | X | ||||
Intraoperative handling of the devices | X | ||||
Recurrence of bleeding | X | X | X | x | |
Adverse Event/Serious Adverse Event | X | X | X | X | |
Local and general complication/re-operation | X | X | X | X | |
Mortality | X |
* date of birth, gender, weight, height,
1) of the operational wound