Table 4.
study schedule | screening visit | study day | post- operative days 1–7 |
---|---|---|---|
written informed consent | x | ||
Demographics | x | ||
medical history, concomitant diseases | x | ||
inclusion/exclusion criteria | x | ||
adverse event monitoring | x | X | |
evaluations/measurements according to table below | x | ||
insertion of two microdialysis probes and equilibration | x | ||
in-vivo calibration of microdialysis probes | x | ||
administration of study drug | x | ||
plasma for pharmacokinetics | x | ||
microdialysate for pharmacokinetics | x | ||
removal of microdialysis probes | x | ||
monitoring incidence of surgical site infection within 1st week | X |