The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

Main Inclusion Criteria (Positive response):

• Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following:

• Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral
• Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular
• Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid
• Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition)
• Approach to the anterior fossa: Subfrontal (uni or bilateral)
• Approach to the midline posterior fossa

Main Exclusion Criteria (Negative response):

• Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months?

• Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week?

• Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks?

• The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:

  • Trans basal approach
  • Total petrosectomy
  • Trans facial approach
  • Trans sphenoidal approach
  • Endoscopic procedures
  • Trans oral approach (and any extension: Le Fort, mandibulotomy)

• The surgical approach is consistent with one of the following approaches?

  • Translabyrinthine approach
  • Retrolabyrinthine approach
  • Transcochlear (limited transpetrosal) approach

• Did the arachnoid membrane and the CSF containing system remain intact during surgery?

• Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?

• Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?