The Fibrin Patch Soft Tissue Study - Full Text View

Purpose

The effectiveness objective of this study is to evaluate whether Fibrin Patch superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Condition	Intervention	Phase
Hemostasis	Drug: Fibrin Patch Device: SURGICEL™	Phase II

ChemIDplus related topics:

Fibrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:

Proportion of subjects achieving hemostatic success at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. Hemostasis is defined as no detectable bleeding at the target-bleeding site. [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving hemostatic success at 10 minutes following randomization [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Incidence of treatment failures [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
Incidence of adverse events that are potentially related to bleeding at the TBS [ Time Frame: Intra-operative up to 1 month ] [ Designated as safety issue: Yes ]
Incidence of adverse events that are potentially related to thrombotic events [ Time Frame: 30 day (+14 days) ] [ Designated as safety issue: Yes ]
Incidence of adverse events potentially related to transfusion exposure [ Time Frame: 30 Days (+14 days) ] [ Designated as safety issue: Yes ]
Incidence of re-treatment at the TBS [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 30 days (+14 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Fibrin Patch Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
2: Active Comparator SURGICEL™ Absorbable Hemostat	Device: SURGICEL™ Absorbable hemostat

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
Subject with TBS within an actively infected field
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
Subjects with known intolerance to blood products or to one of the components of the study product
Subjects unwilling to receive blood products
Subjects with 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: NCT00658723

Contacts


Contact: Jonathan Batiller, MBA	908-218-2492	jbatill2@ethus.jnj.com

Locations


United States, Alabama
	University of Alabama	Active, not recruiting
	Birmingham, Alabama, United States, 35294

United States, Florida
	Jacksonville Center for Clinical Research	Recruiting
	Jacksonville, Florida, United States, 32216
	Baptist Hosptial	Recruiting
	Miami, Florida, United States, 33173

United States, Georgia
	Medical College of Georgia	Recruiting
	Augusta, Georgia, United States, 30912
	Emory University Hospital	Recruiting
	Atlanta, Georgia, United States, 30322

United States, Maryland
	University of Maryland Medical Center	Recruiting
	Baltimore, Maryland, United States, 21201
	St. Agnes Healthcare, Inc.	Recruiting
	Baltimore, Maryland, United States, 21229

United States, New York
	Memorial Sloan Kettering	Not yet recruiting
	New York, New York, United States, 10065
	Long Island Jewish Medical Center	Not yet recruiting
	NEw Hyde Park, New York, United States, 11040

United States, North Carolina
	Duke Medical Center	Not yet recruiting
	Durham, North Carolina, United States, 27710

United States, Pennsylvania
	Lehigh Valley Hospital	Recruiting
	Allentown, Pennsylvania, United States, 18103

United States, Texas
	Weill Medical Colleges of Cornell University - Methodist Hospital	Recruiting
	Houston, Texas, United States, 77030
	The University of Texas MD Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Ethicon, Inc.

OMRIX Biopharmaceuticals

Investigators


Study Director:	James Hart, M.D.	Ethicon, Inc.

More Information

Responsible Party:	Ethicon, Inc. ( Dr. James Hart, Medical Monitor )
Study ID Numbers:	400-07-002
First Received:	April 11, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00658723
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thrombin

Hemorrhage

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Ethicon, Inc. OMRIX Biopharmaceuticals
Information provided by:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT00658723