Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

Exclusion Criteria

• •1. Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
• •2. Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery
• •3. Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
• •4. Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
• •5. Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for ≥8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)
• •6. Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol \[PEG\], trilysine amine)
• •7. Patients with a known hypersensitivity to US Federal Drug \& Cosmetic Blue #1 dye
• •8. Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature \>100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of \<20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters
• •9. Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
• •10. Female patients who are nursing
• •11. Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrolment or anticipated in the 60-day Follow-up period
• •12. Patients with severely altered renal function as confirmed by local laboratory reference ranges for serum creatinine and/or hepatic function (alanine aminotransferase \[ALT\], aspartate aminotransferase \>3 × upper limit of normal \[ULN\])
• •13. Patients who currently have or have had a compromised immune system (such as Acquired Immune Deficiency Syndrome \[AIDS\]) or autoimmune disease, or were on chronic immunosuppressant agents
• •14. Patients with uncontrolled diabetes as evidenced by the institution's standard of care (glycated haemoglobin \[HbA1c\] \>7%, blood glucose, etc.)
• •15. Patients with traumatic injuries to the head
• •16. Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff
• •17. Patients requiring surgical approaches that would not allow sutured dural closure such as trans-sphenoidal or translabyrinthine/-petrosal/-mastoid. Superficial penetration of mastoid air cells is allowed
• •18. Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure
• •19. Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura
• •20. Patients with confined bony structures where nerves are present and neural compression may result due to swelling