Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2006

Conditions
Blood Loss, Surgical
Interventions
DRUG

Fibrin Sealant 2 (FS2)

FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL

DEVICE

Oxidized Regenerated Cellulose (Surgicel)

Commercially available Surgicel used within label.

Trial Locations (16)

10029

Mt. Sinai Hospital, New York

13202

GYN Oncology Associates, Syracuse

15206

Children's Hospital of Pittsburgh, Pittsburgh

18103

Lehigh Valley Hospital, Allentown

19096

Lankenau Hospital, Wynnewood

21229

St. Agnes Healthcare, Inc., Baltimore

30912

Medical College of Georgia, Augusta

32216

Jacksonville Center for Clinical Research, Jacksonville

33173

Miami Research Associates, Miami

50309

The Iowa Clinic, Des Moines

77030

MD Anderson Cancer Center, Houston

The Methodist Hospital, Houston

90027

Children's Hospital of Los Angeles, Los Angeles

97239

Oregon Health and Science University, Portland

02114

Massachusetts General Hospital, Boston

08103

Cooper University Hospital, Camden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

OMRIX Biopharmaceuticals

INDUSTRY

lead

Ethicon, Inc.

INDUSTRY

NCT00307515 - Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery | Biotech Hunter | Biotech Hunter