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

Omrix Biopharmaceuticals Ltd0 sites135 target enrollmentFebruary 25, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: Omrix Biopharmaceuticals Ltd
Enrollment: 135
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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\-25 cm of H20 for 5\-10 seconds.
•Administration of perioperative antibiotic prophylaxis
•Age \>\= 18 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 wide enough based on the surgeon's judgement to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
•Are the trial subjects under 18? no

•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 (6 months) low dose steroid therapy for existing chronic/inflammatory conditions to be resumed within 7 days following surgery. However, postoperative tapered high\-dose steroids are permitted.
•Subjects with severely altered renal function as confirmed by local lab reference ranges for serum creatinine and/or hepatic function \[ALT, AST \> 5 x upper limit of norm (ULN)]
•Evidence of an infection indicated by any one of the following: clinical
•diagnosis of infection, fever, 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 or treatments significantly compromising the immune system (such as AIDS).
•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.