drugset / Trial / NCT02309645

The Paediatric EVICEL® Neuro Study

NCT02309645

Phase 3 Terminated 40 enrolled Ethicon, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight closure.

Timeline

Start
2014-10-01
Primary completion
2021-08-17
Completion
2021-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic Topical