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

PHASE3CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

October 11, 2016

Primary Completion Date

August 22, 2018

Study Completion Date

August 22, 2018

Conditions
Cerebrospinal Fluid Leak
Interventions
DRUG

FS VH S/D 500 s-apr

DEVICE

DuraSeal Dural Sealant

Trial Locations (25)

15006

University Hospital Motol, Praha 5 - Motol

15030

Hospital Na Homolce, Prague

15213

University of Pittsburgh Medical Center, Pittsburgh

18057

University Hospital Rostock, Rostock

19140

Temple University School of Medicine, Philadelphia

22903

University of Virginia School of Medicine, Charlottesville

28040

University Hospital Foundation Jimenez Diaz, Madrid

28041

University Hospital 12 de Octubre, Madrid

43201

The Ohio State University, Columbus

44106

University Hospitals Case Medical Center, Cleveland

46014

University General Hospital of Valencia, Valencia

48202

Henry Ford Hospital, Detroit

50005

University Hospital Hradec Kralove, Hradec Králové

55455

University of Minnesota, Minneapolis

62500

University Hospital Brno, Brno

62702

Southern Illinois University School of Medicine, Springfield

65691

St. Anne's University Hospital Brno, Brno

70852

University Hospital Ostrava, Ostrava

77030

Houston Methodist Neurological Institute, Houston

81925

Hospital Bogenhausen Municipal Hospital, Munich

01199

Baystate Medical Center, Springfield

04103

University Hospital Leipzig, Leipzig

08916

University Hospital Germans Trias I Pujol, Badalona

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

07010

University Hospital Son Espases, Palma de Mallorca

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT02891070 - Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery | Biotech Hunter | Biotech Hunter