Baxter Healthcare Corporation, Deer-field, Illinois.
MPI Research Inc, Mat-tawan, Michigan.
Neurosurgery. 2018 Mar 1;82(3):397-406. doi: 10.1093/neuros/nyx216.
Cerebrospinal fluid (CSF) leaks increase postoperative risk for complication, likelihood of reoperation, and costs.
To investigate a novel, self-adhering polyethylene glycol-coated collagen pad (PCC) as a dural substitute relative to Duragen XS (DGX; Integra LifeSciences Corporation, Plainsboro, New Jersey) and as a dural sealant relative to Tachosil (Takeda Austria GmbH, Linz, Austria), a fibrinogen and thrombin-coated collagen pad (FTC).
A canine supratentorial durotomy surgical model was used to investigate the safety and efficacy of PCC. For safety, 4 animals were bilaterally treated with DGX or PCC and recovered for 1, 8, or 16 wk; total 24 animals. Each animal underwent physical and neurological examinations weekly and 16-wk animals underwent a magnetic resonance imaging (MRI) examination at each time point. For efficacy, 9 animals were unilaterally treated with FTC or PCC and underwent a burst pressure test intraoperatively or 14 d postoperatively; total 36 animals.
In the safety study, no abnormal clinical signs or changes were noted on physical and neurological examinations, or in clinical pathology, CSF analysis or histopathology of DGX or PCC-treated animals. No consistent signs of cerebral compression, CSF leak, hemorrhage, or hydrocephalus were noted on MRI. In the efficacy study, no significant difference was found between FTC and PCC at each time point or overall (13.9 vs 12.3 mm Hg, n = 18 per group, P = .46).
PCC is safe for use as a dural substitute and effective as a dural sealant. The novel, self-adhering combination of a polyethylene glycol-based sealant and a collagen pad may offer unique benefits to the advancement of duraplasty.
脑脊液（CSF）漏增加术后并发症风险、再次手术可能性和成本。
研究一种新型的、自粘的聚乙二醇涂层胶原垫（PCC），作为硬脑膜替代物，与 Duragen XS（DGX；Integra LifeSciences Corporation，Plainsboro，New Jersey）相比，以及作为硬脑膜密封剂，与 Tachosil（Takeda Austria GmbH，Linz，Austria）相比，即纤维蛋白原和凝血酶涂层胶原垫（FTC）。
使用犬颅顶硬脑膜切开术手术模型研究 PCC 的安全性和有效性。为了安全性，4 只动物双侧接受 DGX 或 PCC 治疗，并在 1、8 或 16 周时恢复；总共 24 只动物。每只动物每周接受一次身体和神经检查，16 周的动物在每个时间点进行磁共振成像（MRI）检查。为了有效性，9 只动物单侧接受 FTC 或 PCC 治疗，并在术中或术后 14 天进行爆裂压力测试；总共 36 只动物。
在安全性研究中，DGX 或 PCC 治疗的动物在体格和神经检查、临床病理学、CSF 分析或组织病理学方面均未出现异常临床症状或变化。MRI 上未发现明显的脑受压、CSF 漏、出血或脑积水迹象。在有效性研究中，FTC 和 PCC 在每个时间点或总体上（每组 18 只，分别为 13.9 和 12.3mmHg，P=.46）均无显著差异。
PCC 可安全用作硬脑膜替代物，作为硬脑膜密封剂有效。新型的、自粘的聚乙二醇基密封剂和胶原垫的组合可能为硬脑膜成形术的发展提供独特的优势。
