Antibiotikapenetration og vævsrespons ved infektion og rekonstruktiv kirurgi i hoved-hals regionen

Condition studied

Treatment and prevention of post operative infections

Investigational medicinal product(s)

Eligibility

Primary endpoint

T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.

Endpoint detail

Pharmacokinetic parameters (Cmax, AUC, Tmax and T½) in tissue and plasma, Concentrations of glucose, lactate, pyruvate and glycerol, as well as inflammatory proteins, in microdialysate samples