A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair

Conditions: tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral surgery.

Registration Number: EUCTR2009-016501-41-DE

Lead Sponsor: Omrix Biopharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

Preoperative
•Patient undergoing elective craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following suture closure of the dural incision. CSF leakage will be evaluated during a period of Valsalva of 20 cm of H20 for 5-10 seconds.
•Age ? 3 years
•Patients 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.

Intraoperative
•Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted.
•The cuff of native dura along the craniotomy edge is ? 10 mm wide, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Preoperative:
•Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.
•Chemotherapy scheduled within 7 days following surgery.
•Radiation therapy to the head scheduled within 7 days following surgery.
•Long-term low dose steroid therapy to be resumed within 7 days following surgery. However, postoperative tapered high-dose steroids are permitted.
•Subjects with severely altered renal (serum creatinine > 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 > 38?C, WBC < 3500/uL or > 13000/uL, positive urine culture, positive blood culture, positive chest X-ray, evidence of infection along the planned surgical path. A WBC count of <20000 is permitted if the patient is being treated with steroids in the absence of all the other infection parameters.
•Conditions compromising the immune system; existence of autoimmune disease.
•Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
•Non-compliant or insufficient treatment of diabetes mellitus ?glycosylated hemoglobin (HbA1c) > 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.
•Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period.
•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:

•Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dura cuff.
•Failure to administer preoperative antibiotic prophylaxis
•Use of implants made of synthetic materials coming into direct contact with dura (e.g., 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
•Patient has a gap of greater than 2mm after primary dural closure.
•Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection.
•Two or more separate dura defects
•Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.