A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair
A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair
复制标题
DOI：
10.1093/ons/opw004
复制
发表时间：
2017-04-01
影响因子：
2.3
通讯作者：
Asher, Anthony L.
中科院分区：
文献类型：
--
作者：
Tew, John M., Jr.;Strong, Michael J.;Asher, Anthony L.
背景技术背景：水密性硬脑膜修补术对于最大限度地减少继发于脑脊液（CSF）漏的术后并发症的风险至关重要。目的：评价一种新型水凝胶Adherus硬脑膜密封剂与对照组DuraSeal硬脑膜密封剂系统相比作为硬脑膜修补标准方法的辅助治疗的安全性和有效性。方法：在这项设计为非劣效性、单盲研究的17个中心、前瞻性、随机临床试验中，124名患者接受了Adherus硬脑膜封闭剂（试验封闭剂），126名患者接受了DuraSeal（对照）。主要复合终点为硬膜修复后Valsalva操作期间无任何术中CSF渗漏、CSF渗漏/假性脑膜膨出和手术部位计划外再治疗的患者比例。然后将每个组分作为次要终点进行单独分析。术后患者随访4 mo。结果：120天随访时，试验密封剂组达到主要复合终点的比例为91.2%，对照组为90.6%，因此表明试验密封剂在统计学上显著不劣于DuraSeal（P = 0.0049）。14 d时主要复合终点的事后分析证明试验密封剂优于对照（P =. 030）。在对照组的主要终点失败往往发生在早期的随访期间，而大多数的测试硬脑膜密封剂失败，确定通过协议要求的放射成像在120天的随访vision.CONCLUSION：测试密封剂，Adherus硬脑膜密封剂，是一个实用的，安全的，有效的辅助实现水密性硬脑膜关闭后，在颅脑手术。
BACKGROUND: A watertight dural repair is critical to minimizing the risk of postoperative complications secondary to cerebrospinal fluid (CSF) leaks.OBJECTIVE: To evaluate the safety and efficacy of a novel hydrogel, Adherus Dural Sealant, when compared with control, DuraSeal Dural Sealant System, as an adjunct to standard methods of dural repair.METHODS: In this 17-center, prospective, randomized clinical trial designed as a noninferiority, single-blinded study, 124 patients received Adherus Dural Sealant (test sealant) and 126 received DuraSeal (control). The primary composite endpoint was the proportion of patients who were free of any intraoperative CSF leakage during Valsalva maneuver after dural repair, CSF leak/pseudomeningocele, and unplanned retreatment of the surgical site. Each component was then analyzed individually as a secondary endpoint. Patients were followed for 4 mo after surgery.RESULTS: The primary composite endpoint at the 120-d follow-up was achieved in 91.2% of the test sealant group compared with 90.6% of the control, thus showing that the test sealant was statistically significantly noninferior to DuraSeal (P = .0049). Post hoc analysis of the primary composite endpoint at 14 d demonstrated superiority of the test sealant over the control (P =. 030). Primary endpoint failures in the control group tended to occur early in follow-up period, while a majority of test dural sealant failures were identified through protocol-required radiographic imaging at the 120-d follow-up visit.CONCLUSION: The test sealant, Adherus Dural Sealant, is a practical, safe, and effective adjunct to achieving a watertight dural closure after primary dural closure in cranial procedures.