NCT00859508已完成不适用
A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
Synthes USA HQ, Inc.16 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 16
- 主要终点
- Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
研究概览
简要总结
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 75 years of age
- •Patient is scheduled for an elective cranial procedure requiring a dural incision
- •Patient has an MRI no earlier than two months prior to the date of enrollment
- •Surgical wound is expected to be Class I/clean
- •Patient is available and willing to participate in the investigation for the duration of the study
- •Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.
排除标准
- •Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
- •Patient is somnolent or comatose (Glasgow score< 8)
- •Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
- •Patient will require use of a dural adhesive or sealant
- •Patient has known hydrocephalus
- •Patient's life expectancy is less than 6 months
- •Patient has a systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 101°F, positive blood culture and/or a positive chest x-ray for acute infectious process
- •Patient has known allergy to device component (cellulose)
- •Patient is an acute cranial trauma surgical case
- •Patient has a local cranial infection
- •Patient has had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or has chemotherapy and/or radiation treatment planned 10 weeks post surgery
- •Patient has been clinically diagnosed with malignancy (other than basal cell carcinoma or low grade glioma), uncontrolled diabetes, sepsis, systemic collagen disease
- •Patient has creatinine levels > 2.0 mg/dL
- •Patient has total bilirubin level > 2.5 mg/dL
- •Patent has clinically significant coagulopathy with a partial thromboplastin time (PTT) ≥ 35, international normalized ratio (INR) ≥ 1.2, or is receiving Warfarin or Coumadin
- •Patient has a compromised immune system or autoimmune disease (white blood cell (WBC) count <4000/uL or >20,000/uL)
- •Patient is participating in another clinical trial using investigational devices/drugs
- •Patient is pregnant or breastfeeding or wishes to become pregnant during the course of the study
- •Patient is unable or unwilling to sign a consent form
结局指标
主要结局
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
时间窗: 6 months
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
次要结局
- Wound Healing Assessment(up to 6 months)
- Radiographic Evaluation(6 months)
- Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)(up to 6 months)
- Modified Rankin Scale (Patient Function Assessment)(up to 6 months)
- Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)(up to 6 months)
研究者
研究点 (16)
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