دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Safety and effectiveness of Evicel ®  fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery.
المؤلفون: Sivakumar G; Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK. gsivakumar1@nhs.net., Magdum S; John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK., Aquilina K; Great Ormond Street Hospital, London, WC1N 3JH, UK., Kandasamy J; Royal Hospital for Sick Children, Sciennes Road, Edinburgh, EH9 1LF, UK., Josan V; Royal Manchester Children's Hospital, Oxford Road, Manchester, M13 9WL, UK., Ilie B; Ethicon, Inc., 1000 US-202 South, Raritan, NJ, 08869, USA., Barnett E; Ethicon, Inc., 8 Deer Park, Livingston, EH54 8AF, United Kingdom., Kocharian R; Ethicon, Inc., 1000 US-202 South, Raritan, NJ, 08869, USA., Pettorini B; Alder Hey Children's Hospital, Eaton Road, Liverpool, L12 2AP, UK.
المصدر: Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery [Childs Nerv Syst] 2024 Sep; Vol. 40 (9), pp. 2735-2745. Date of Electronic Publication: 2024 May 10.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Springer International Country of Publication: Germany NLM ID: 8503227 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1433-0350 (Electronic) Linking ISSN: 02567040 NLM ISO Abbreviation: Childs Nerv Syst Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Berlin : Springer International, c1985-
مواضيع طبية MeSH: Fibrin Tissue Adhesive*/therapeutic use , Neurosurgical Procedures*/methods , Cerebrospinal Fluid Leak* , Dura Mater*/surgery, Humans ; Female ; Male ; Child ; Child, Preschool ; Adolescent ; Infant ; Postoperative Complications/prevention & control ; Treatment Outcome ; Tissue Adhesives/therapeutic use ; Prospective Studies ; Suture Techniques
مستخلص: 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).
(© 2024. Crown.)
التعليقات: Erratum in: Childs Nerv Syst. 2024 Sep;40(9):2747-2750. doi: 10.1007/s00381-024-06503-8. (PMID: 38995396)
References: World Neurosurg. 2017 Oct;106:615-624. (PMID: 28729143)
ISRN Surg. 2014 Mar 04;2014:203943. (PMID: 24729902)
Spine (Phila Pa 1976). 2005 Jul 1;30(13):E347-51. (PMID: 15990651)
Neurosurgery. 2012 Apr;70(4):936-43; discussion 943. (PMID: 21993188)
Surg Neurol Int. 2023 Mar 31;14:114. (PMID: 37151431)
Neurosurgery. 2008 Oct;63(4 Suppl 2):352-8; discussion 358. (PMID: 18981842)
J Neurosurg Pediatr. 2019 Nov 29;25(3):228-234. (PMID: 31783365)
Ann Neurol. 2016 Jan;79(1):18-26. (PMID: 26580862)
Neurosurgery. 2000 Dec;47(6):1463-7. (PMID: 11126922)
Neurosurgery. 2011 Oct;69(4):921-8; discussion 929. (PMID: 21552173)
J Neurosci Res. 2003 Jun 15;72(6):734-46. (PMID: 12774314)
BMJ Open. 2021 Dec 16;11(12):e052553. (PMID: 34916315)
Neurosurgery. 2023 Jun 1;92(6):1177-1182. (PMID: 36688661)
World Neurosurg. 2018 Jun;114:e743-e746. (PMID: 29551726)
Oper Neurosurg (Hagerstown). 2017 Apr 1;13(2):204-212. (PMID: 28927211)
Childs Nerv Syst. 2021 May;37(5):1439-1447. (PMID: 33538867)
Surg Neurol. 2005 Dec;64(6):490-3, discussion 493-4. (PMID: 16293457)
Acta Neurochir (Wien). 2002 Jan;144(1):63-9. (PMID: 11807648)
J Neurosurg. 2014 Sep;121(3):735-44. (PMID: 25036199)
Pediatr Neurosurg. 1999 Mar;30(3):113-21. (PMID: 10352412)
J Pediatr Neurosci. 2017 Jul-Sep;12(3):245-250. (PMID: 29204199)
Arch Surg. 2004 Nov;139(11):1148-54. (PMID: 15545559)
Drugs. 2011 Oct 1;71(14):1893-915. (PMID: 21942978)
Pediatr Neurol. 2021 Sep;122:89-97. (PMID: 34325983)
J Neurosurg Pediatr. 2023 Feb 03;31(4):313-320. (PMID: 36738466)
BMJ Open. 2021 Jul 28;11(7):e049098. (PMID: 34321304)
Chin Med J (Engl). 2022 Oct 20;135(20):2506-2508. (PMID: 36583870)
J Pharmacol Exp Ther. 2002 Apr;301(1):168-73. (PMID: 11907171)
Br J Neurosurg. 2015 Feb;29(1):11-17. (PMID: 25112563)
Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS182-6; discussion ONS186-7. (PMID: 18728598)
Surg Technol Int. 2014 Nov;25:265-70. (PMID: 25419954)
Epilepsia. 1982 Feb;23(1):35-45. (PMID: 7056249)
Br J Surg. 2010 Dec;97(12):1784-9. (PMID: 20730858)
World Neurosurg. 2012 Nov;78(5):498-504. (PMID: 22381303)
World Neurosurg. 2018 Oct;118:368-376.e1. (PMID: 29969744)
Clin Appl Thromb Hemost. 2011 Nov-Dec;17(6):572-7. (PMID: 21873356)
PLoS One. 2016 Apr 27;11(4):e0151533. (PMID: 27119993)
فهرسة مساهمة: Keywords: Cerebrospinal fluid leak; Dural sealing; Fibrin sealant; Pediatric neurosurgery
سلسلة جزيئية: ClinicalTrials.gov NCT02309645
المشرفين على المادة: 0 (Fibrin Tissue Adhesive)
0 (Tissue Adhesives)
تواريخ الأحداث: Date Created: 20240510 Date Completed: 20240814 Latest Revision: 20240816
رمز التحديث: 20240816
مُعرف محوري في PubMed: PMC11322203
DOI: 10.1007/s00381-024-06434-4
PMID: 38727726
قاعدة البيانات: MEDLINE
الوصف
تدمد:1433-0350
DOI:10.1007/s00381-024-06434-4