VER-01 Sealing Sutured Cranial Dural Repair Study

INTERVENTION: Subjects, who are undergoing sutured dural repair following procedures in the supratentorial region or posterior fossa, will be evaluated for intra‐operative cerebrospinal fluid (CSF) leakage with a baseline Valsalva maneuver performed to a pressure between 20‐25 cm H2O for 5‐10 seconds. If a spontaneous leak is apparent immediately after dural closure, no Valsalva maneuver will be performed. Subjects who have exudative CSF leakage are enrolled will be randomized to VER‐01 or Beriplast P in a 1:1 allocation ratio. CONDITION: Elective craniotomy or decompressive craniectomy surgery in supratentorial or po PRIMARY OUTCOME: Incidence rate of post‐operative CSF leak or pseudomeningocele in the surgical area within 7 days (plus or minus 2 days) following surgery.; Computerized tomography (CT) scan within 5 mm slice thickness is necessary after surgery within 7 days (plus or minus 2 days) following surgery. The imaging is not necessary when CSF leak is visually apparent. INCLUSION CRITERIA: Pre‐operative 1.Subjects undergoing an elective craniotomy or decompressive craniectomy surgery in supratentorial or posterior fossa 2.At least 18 years of age at the time of informed consent. 3.Willingness to comply with the protocol. 4.Willingness to give consent before all study‐related activities. Intra‐operative 1.Surgical wound classification Class I. Superficial penetration of mastoid air cells during partial mastoidectomy is permitted. 2.The cuff of native dura along the craniotomy edge on each side is adequate, based on judgement of principal investigator or sub‐investigator, to facilitate suturing and to allow for sufficient surface area for adherence of the sealant 3.Presence of intra‐operative spontaneous cerebrospinal fluid (CSF) leakage following sutured dural closure or after Valsalva maneuver. If a spontaneous leak is apparent immediately after dural closure, no Valsalva maneuver will be performed.