A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery.

IF 1.5 3区 医学 Q2 PEDIATRICS European Journal of Pediatric Surgery Pub Date : 2024-12-01 Epub Date: 2024-03-29 DOI:10.1055/s-0044-1785443
Simon Kenny, Hany Gabra, Nigel J Hall, Helene Flageole, Bogdan Illie, Ellie Barnett, Richard Kocharian, Khalid Sharif
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Abstract

Introduction:  Data on the use of fibrin sealants to control intraoperative bleeding in children are scarce. Evicel Fibrin Sealant (Ethicon Inc., Raritan, New Jersey, United States) was found safe and effective in clinical trials of adults undergoing various surgery types. We evaluated the safety and efficacy of Evicel versus Surgicel Absorbable Hemostat (Ethicon Inc.) as adjunctive topical hemostats for mild/moderate raw-surface bleeding in pediatric surgery.

Methods:  A phase III randomized clinical trial was designed as required by the European Medicines Agency's Evicel Pediatric Investigation Plan: 40 pediatric subjects undergoing abdominal, retroperitoneal, pelvic, or thoracic surgery were randomized to Evicel or Surgicel, to treat intraoperative mild-to-moderate bleeding. Descriptive analyses included time-to-hemostasis and rates of treatment success (4, 7, 10 minutes), intraoperative treatment failure, rebleeding, and thromboembolic events.

Results:  Forty of 130 screened subjects aged 0.9 to 17 years were randomized 1:1 to Evicel or Surgicel. Surgeries were predominantly open abdominal procedures. The median bleeding area was 4.0 cm2 for Evicel and 1.0 cm2 for Surgicel. The median time-to-hemostasis was 4.0 minutes for both groups. The 4-, 7-, and 10-minute treatment success rates were 80.0% versus 65.0%, 100.0% versus 80.0%, and 95.0% versus 90.0%, whereas treatment failure rates were 5.0% versus 25.0%, for Evicel and Surgicel, respectively. No deaths or thrombotic events occurred. Re-bleeding occurred in 5.0% of Evicel and 10.0% of Surgicel subjects.

Conclusions:  In accordance with adult clinical trials, this randomized study supports the safety and efficacy of Evicel for controlling mild-to-moderate surgical bleeding in a broad range of pediatric surgical procedures.

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Evicel 纤维蛋白密封剂作为小儿外科手术辅助止血剂的安全性和有效性研究。
导言:使用纤维蛋白密封剂控制儿童术中出血的数据很少。Evicel 纤维蛋白密封剂(Ethicon Inc.我们评估了 Evicel 与 Surgicel 可吸收止血剂(Ethicon Inc:按照欧洲药品管理局 Evicel 儿科调查计划的要求,设计了一项 III 期随机临床试验:40名接受腹部、腹膜后、盆腔或胸部手术的儿科受试者随机接受Evicel或Surgicel治疗术中轻度至中度出血。描述性分析包括止血时间、治疗成功率(4、7、10 分钟)、术中治疗失败率、再出血率和血栓栓塞事件发生率:在 130 名年龄介于 0.9 岁至 17 岁之间的受试者中,有 40 人按 1:1 的比例随机接受 Evicel 或 Surgicel 治疗。手术主要是开腹手术。Evicel 的中位出血面积为 4.0 平方厘米,Surgicel 为 1.0 平方厘米。两组止血时间的中位数均为 4.0 分钟。Evicel和Surgicel的4分钟、7分钟和10分钟治疗成功率分别为80.0%对65.0%、100.0%对80.0%和95.0%对90.0%,而治疗失败率分别为5.0%对25.0%。无死亡或血栓事件发生。5.0%的Evicel受试者和10.0%的Surgicel受试者出现再出血:这项随机研究与成人临床试验结果一致,支持 Evicel 在各种儿科外科手术中控制轻度至中度外科出血的安全性和有效性。
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来源期刊
CiteScore
3.90
自引率
5.60%
发文量
66
审稿时长
6-12 weeks
期刊介绍: This broad-based international journal updates you on vital developments in pediatric surgery through original articles, abstracts of the literature, and meeting announcements. You will find state-of-the-art information on: abdominal and thoracic surgery neurosurgery urology gynecology oncology orthopaedics traumatology anesthesiology child pathology embryology morphology Written by surgeons, physicians, anesthesiologists, radiologists, and others involved in the surgical care of neonates, infants, and children, the EJPS is an indispensable resource for all specialists.
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