Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Condition: Cerebrospinal Fluid Leak
MeSH terms: Cerebrospinal Fluid Leak
Intervention: FS VH S/D 500 s-apr; DuraSeal Dural Sealant
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cranial Surgery; Cerebrospinal Fluid Leak; Tisseel

Summary:

      The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for
      use as an adjunct to sutured dural repair in cranial surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST
             region

          2. Patients must be willing and able to participate in the study and provide written IC
             before any protocol specific assessment is performed

          3. Patients must be willing to receive peri-operative antibiotic prophylaxis

          4. Female patients of childbearing potential must present with a negative serum pregnancy
             test, and must agree to employ adequate birth control measures [restricted to
             abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed
             hormonal products] for the duration of their participation in the study

          5. Patients are willing and able to comply with the requirements of the protocol

        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