Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

Phase 3 Completed 224 enrolled Baxter Healthcare Corporation

RandomizedParallel-groupSingle-blindPrevention

Summary

The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.

Timeline

Start: 2016-10-11
Primary completion: 2018-08-22
Completion: 2018-08-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FS VH S/D 500 s-apr	Protein / enzyme biologic	—	—

Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

Summary

Timeline

Drugs

Indications