Bioseal Dural Sealing Study BIOS-14-001

Phase 3 Completed 200 enrolled Guangzhou Bioseal Biotechnology Co., Ltd.

RandomizedParallel-groupSingle-blindTreatment

Summary

A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair

Timeline

Start: 2017-09-14
Primary completion: 2019-09-20
Completion: 2019-09-20

Publications

Du S, Zhao J, Qiao G, Wu S, Han Y. Cost-Effectiveness Analysis of the Application of a Porcine-Derived Fibrin Sealant for the Treatment of Cerebrospinal Fluid Leak in China. Clin Ther. 2022 Apr;44(4):575-584. doi: 10.1016/j.clinthera.2022.02.010. Epub 2022 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bioseal	Unknown	—	Topical

Bioseal Dural Sealing Study BIOS-14-001

Summary

Timeline

Publications

Drugs

Indications