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

Omrix Biopharmaceuticals Ltd0 个研究点目标入组 130 人2009年12月30日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 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.
发起方: Omrix Biopharmaceuticals Ltd
入组人数: 130
状态: 进行中（未招募）
最后更新: 14年前

暂无简介。

注册库

who.int

开始日期

2009年12月30日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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:

•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%?.