Fibrin Sealant for the Sealing of Dura Sutures

Inclusion Criteria

Preoperative Inclusion Criteria:

• Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol
• Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures
• Age >= 3 years, either gender

Intraoperative Inclusion Criteria:

• Surgical Wound Classification Class I and Risk Index Category (RIC) 2 mg/dL) and/or hepatic function [ALT, AST > 5 x upper limit of norm (ULN)]
• Evidence of an infection indicated by any one of the following: fever > 101°F, white blood cell (WBC) count 13000/μL, positive blood culture, positive chest X-ray. A positive urine culture (> 10^5 colony-forming units (CFU)/mL) leads to exclusion unless acute cystitis is the sole cause. Evidence of infection along the planned surgical path. A WBC count of 7.5%]
• Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology to be treated
• Existing CSF (ventricular, etc.) drains. Burr holes are permitted as long as the dura remains intact. Cushing cannulation excludes the subject.
• Female subjects of childbearing potential with a positive urine or serum pregnancy test within 24 hours prior to surgery
• Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment
• Scheduled or foreseeable surgery within the follow-up period

Intraoperative Exclusion Criteria:

• Dura injury during craniotomy / craniectomy that cannot be eliminated by recreating a sufficiently wide native dura hem
• Failure to administer preoperative antibiotic prophylaxis
• Use of implants made of synthetic materials coming into direct contact with dura (e.g., polytetrafluoroethylene (PTFE) patches, shunts, ventricular and subdural drains)
• Placement of Gliadel wafers
• Chiari 1 subjects without injury to the arachnoid
• Persistent signs of increased brain turgor
• Use of product(s) other than FS VH S/D 500 s-apr for the sealing of dura sutures, including packing with Gelfoam
• Brain surface visible between suture loops as a manifestation of increased suture tension
• CSF leakage from completed dura sutures presenting as dripping drops, growing beads or running trickles. Slight oozing is consistent with successful dura repair and will not lead to exclusion.
• Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection
• Dura lesion from a recent surgery that cannot be completely excised, including all old suture holes
• Two or more separate dura defects
• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure