EUCTR2009-016501-41-DE进行中（未招募）不适用
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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