evicel® 纤维蛋白密封剂作为接受颅神经外科手术的儿童硬脑膜缝合修复术的辅助用药的安全性和有效性。

IF 1.3 4区 医学 Q4 CLINICAL NEUROLOGY
Child's Nervous System Pub Date : 2024-09-01 Epub Date: 2024-05-10 DOI:10.1007/s00381-024-06434-4
Gnanamurthy Sivakumar, Shailendra Magdum, Kristian Aquilina, Jothy Kandasamy, Vivek Josan, Bogdan Ilie, Ellie Barnett, Richard Kocharian, Benedetta Pettorini
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引用次数: 0

摘要

目的:脑脊液(CSF)漏是硬脑膜内颅脑手术的一个棘手并发症,儿童的风险尤其高。硬脑膜密封剂对成人具有保护作用,但对儿童的研究却很少。我们评估了 Evicel® 纤维蛋白密封剂在儿童颅脑手术中作为硬膜缝合的辅助手段的安全性和有效性:一项多中心试验前瞻性地招募了儿科受试者(® 儿科调查计划),40名受试者在术中以2:1的比例被随机分配到Evicel®或额外的缝合线("缝合线")中。数据分析为描述性分析。疗效终点是治疗成功率,成功率的定义是术中经Valsalva手法刺激后的水密闭合(主要终点)。安全性终点为术后 CSF 渗漏(切口 CSF 渗漏、假门脉或两者兼有)和手术部位并发症(次要终点):40名受试者(0.6-17岁)被随机分配到Evicel®(25人)或Sutures(15人)(意向治疗)。颅内肿瘤是最常见的适应症,手术多为幕上开颅。Evicel® 的成功率为 92.0%,Sutures 的成功率为 33.3%,成功率估计比为 2.76(Farrington-Manning 95% CI [1.53,6.16])。按方案和安全组进行的敏感性分析显示了相似的结果。尽管抢救治疗率较高,但Sutures术后CSF渗漏和伤口并发症的发生率高于Evicel®:这项小规模的前瞻性研究表明,Evicel®疗法在儿童人群中作为主要缝合硬脑膜的辅助疗法是安全有效的。与额外的缝合相比,Evicel®可减少术后CSF渗漏和手术部位并发症。(试验注册:该试验已注册为 NCT02309645 和 EudraCT 2013-003558-26)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Safety and effectiveness of Evicel<sup>®</sup> fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery.

Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery.

Purpose: Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.

Methods: A multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel® or additional sutures ('Sutures'). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints).

Results: Forty subjects (0.6-17 years) were randomized to Evicel® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel®.

Conclusion: This small-scale prospective study shows Evicel® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).

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来源期刊
Child's Nervous System
Child's Nervous System 医学-临床神经学
CiteScore
3.00
自引率
7.10%
发文量
322
审稿时长
3 months
期刊介绍: The journal has been expanded to encompass all aspects of pediatric neurosciences concerning the developmental and acquired abnormalities of the nervous system and its coverings, functional disorders, epilepsy, spasticity, basic and clinical neuro-oncology, rehabilitation and trauma. Global pediatric neurosurgery is an additional field of interest that will be considered for publication in the journal.
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