Trials / Completed
CompletedNCT02891070
Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 224 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FS VH S/D 500 s-apr | |
| DEVICE | DuraSeal Dural Sealant |
Timeline
- Start date
- 2016-10-11
- Primary completion
- 2018-08-22
- Completion
- 2018-08-22
- First posted
- 2016-09-07
- Last updated
- 2019-09-10
- Results posted
- 2019-09-10
Locations
25 sites across 4 countries: United States, Czechia, Germany, Spain
Source: ClinicalTrials.gov record NCT02891070. Inclusion in this directory is not an endorsement.