The EVICEL® Neurosurgery Phase III Study

Inclusion Criteria: * Subjects ≥18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa * Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent. * Surgical wound classification Class I * The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product * Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver Exclusion Criteria: * Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage. * Chemotherapy within 30-days prior to enrollment or scheduled within 7-days following surgery * Radiation therapy to the head within 30-days prior to enrollment or scheduled within 7-days following surgery * A previous craniotomy/craniectomy within 6 months prior to the study surgery. * Known hypersensitivity to the components of the investigational product. * Subjects with a known allergy to FD\&C Blue #1 dye * Subjects with an infection present at the surgical site * Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray. * Female subjects of childbearing potential with a positive …