drugset / Trial / NCT02309645
The Paediatric EVICEL® Neuro Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | — | Topical |