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

Sponsors and Collaborators:	Ethicon, Inc. OMRIX Biopharmaceuticals
Information provided by:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT00307515

Purpose

A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

Condition	Intervention	Phase
Blood Loss, Surgical	Drug: Fibrin Sealant 2 (FS2) Device: Oxidized Regenerated Cellulose (Surgicel)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Cellulose sodium phosphate Beriplast Fibrin Cellulose Phosphocellulose

U.S. FDA Resources

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:

Hemostatic success within 10 minutes. [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Absence of bleeding at pre-defined time points within 10 minutes [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
Incidence of treatment failures [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
Incidence of potential bleeding-related complications [ Time Frame: 24 hr prior to discharge, Day 7-14 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Intraoperative, 24 hr prior to discharge, Day 7-14 ] [ Designated as safety issue: Yes ]

Enrollment:	135
Study Start Date:	February 2006
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fibrin Sealant 2 (FS2)	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
2: Active Comparator Oxidized Regenerated Cellulose (Surgicel)	Device: Oxidized Regenerated Cellulose (Surgicel) Commercially available Surgicel used within label.

Detailed Description:

The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
Subjects must be willing to participate in the study and provide written informed consent

Exclusion Criteria:

Subjects undergoing emergency surgery
Parenchymal or anastomotic bleeding sites will not be considered for randomization
Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
Subjects with known intolerance to blood products or to one for the components of the study product
Subjects unwilling to receive blood products
Subjects with known autoimmune immunodeficiency diseases (including known HIV
Subjects who are known, current alcohol and/or drug abusers
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
Female subjects who are pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307515

Locations

United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Iowa
The Iowa Clinic
Des Moines, Iowa, United States, 50309
United States, Maryland
St. Agnes Healthcare, Inc.
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
GYN Oncology Associates
Syracuse, New York, United States, 13202
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Ethicon, Inc.

OMRIX Biopharmaceuticals

Investigators

Study Director:

James Hart, MD

Ethicon, Inc.

More Information

No publications provided

Responsible Party:	Ethicon ( Jonathan Batiller, MBA )
Study ID Numbers:	400-05-006
Study First Received:	March 23, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00307515 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thrombin
Calcium, Dietary
Fibrin Tissue Adhesive
Blood Loss, Surgical

Intraoperative Complications
Hemorrhage
Hemostatics

Additional relevant MeSH terms:

Pathologic Processes
Coagulants
Fibrin Tissue Adhesive
Therapeutic Uses
Hematologic Agents

Blood Loss, Surgical
Intraoperative Complications
Hemorrhage
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on September 11, 2009