Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Exclusion Criteria

• •Preoperative Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery.
• •Subjects requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch.
• •Subject who previously participated in this study or any investigational drug or device study within 30 days of screening.
• •Subjects with a presence of hydrocephalus. Intraoperative Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
• •Primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea.
• •A gap \> 3 mm after primary closure of the dura mater.