A Single-blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair

You are here

This clinical study is a non-inferiority study designed to evaluate the safety and efficacy of EVICEL® for use as an adjunct to sutured dural repair in cranial surgery as compared to DuraSeal Dural Sealant System. The study will assess both achievement of intra-operative watertight closure of the dural suture line and the occurrence of post-operative CSF leaks. This study will provide additional data to support the development of EVICEL® for use in tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater may occur.

Contact Dr. Stieg: 212-746-4684