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评估一种用于预防颅脑手术中脑脊液漏的密封止血贴片的安全性和有效性。

Evaluation of the safety and effectiveness of a sealant hemostatic patch for preventing cerebrospinal fluid leaks in cranial surgery.

机构信息

Department of Neurosurgery, University Clinical Hospital of Valladolid, Valladolid, Spain.

出版信息

Expert Rev Med Devices. 2021 Nov;18(11):1111-1116. doi: 10.1080/17434440.2021.1988850. Epub 2021 Oct 20.

DOI:10.1080/17434440.2021.1988850
PMID:34601992
Abstract

BACKGROUND

Cerebrospinal fluid (CSF) leak remains a significant source of morbidity after neurosurgical procedures. The objective is to evaluate the effectiveness and safety of a polyethylene glycol-coated collagen patch (PCC) in different neurosurgical procedures.

METHODS

A retrospective, single-center cohort study in patients who underwent a cranial neurosurgical procedure. After collecting multiple data variables, patients were divided into two groups depending on the use of PCC as sealant on dural closure following procedures.

RESULTS

Data from 230 patients were collected (PCC, 128; control group, 102). Incidence of CSF leakage was significantly lower in the PCC group (p < .001). Complications that were significantly lower in PCC than the control group included surgical infection (p = .022), and hydrocephalus (p = .017), as well as reduced rates of reintervention (p < .001) and shorter hospital stays (p = .028). Factors associated with a higher incidence of CSF leakage included posterior fossa procedures, reinterventions, and the need for CSF drainage placement. PCC reduced the risk of suffering CSF leakage by more than 75% (p = .002) once adjusted for age, surgical approach, type of cranial opening, reintervention, CSF drainage, dural substitute, and dural defect coverage.

CONCLUSIONS

Our findings confirm PCC as an effective means of preventing CSF leakage following cranial neurosurgery with fewer associated complications.

摘要

背景

脑脊液(CSF)漏仍然是神经外科手术后发病率的一个重要来源。目的是评估聚乙二醇涂层胶原贴(PCC)在不同神经外科手术中的有效性和安全性。

方法

这是一项回顾性、单中心的队列研究,纳入了接受颅神经外科手术的患者。在收集了多个数据变量后,根据术后硬脑膜关闭时是否使用 PCC 作为密封剂,将患者分为两组。

结果

共收集了 230 名患者的数据(PCC 组 128 名,对照组 102 名)。PCC 组 CSF 漏的发生率明显较低(p<0.001)。PCC 组显著低于对照组的并发症包括手术感染(p=0.022)和脑积水(p=0.017),以及降低的再干预率(p<0.001)和缩短的住院时间(p=0.028)。与 CSF 漏发生率较高相关的因素包括后颅窝手术、再干预和需要放置 CSF 引流。一旦调整了年龄、手术途径、颅腔开口类型、再干预、CSF 引流、硬脑膜替代物和硬脑膜缺损覆盖物,PCC 可使 CSF 漏的风险降低 75%以上(p=0.002)。

结论

我们的研究结果证实 PCC 是预防颅神经外科术后 CSF 漏的有效方法,且相关并发症较少。

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