3 results
The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior in efficacy to the common practice of CSD insertion by wound closure, measured…
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…