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

ABSTRACT:

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 descriptiv

SUBMITTER: Sivakumar G 

PROVIDER: S-EPMC11322203 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature