The Fibrin Patch Soft Tissue Study

Hemostasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658723
• Other study ID #: 400-07-002
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2008
• Last updated: September 9, 2014
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2014
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The effectiveness objective of this study is to evaluate whether Fibrin Patch is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemostasis

Intervention

Drug:
• Fibrin Pad
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).

Device:
• SURGICEL™
Absorbable hemostat

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Emory University Hospital	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	St. Agnes Healthcare, Inc.	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Weill Medical Colleges of Cornell University - Methodist Hospital	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Baptist Hosptial	Miami	Florida
United States	Long Island Jewish Medical Center	NEw Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving Hemostatic Success	Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.	Intra-operative	No
Secondary	Proportion of Subjects Achieving Hemostatic Success	The proportion of subjects achieving hemostatic success at 10 minutes following randomization	10 minutes	No
Secondary	Incidence of Treatment Failures	If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.	Intra-operative	No
Secondary	Incidence of Adverse Events That Are Potentially Related to Bleeding	The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).	Intra-operative up to 1 month (+14 days)	Yes
Secondary	Incidence of Adverse Events That Are Potentially Related to Thrombotic Events	The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism	Intra-operative up to 1 month (+14 days)	Yes
Secondary	Incidence of Adverse Events Potentially Related to Transfusion Exposure	The types of events that were potentially related to transfusion exposure could have include hypocalcemia.	Intra-operative up to 1 month (+14 days)	Yes
Secondary	Incidence of Re-treatment	The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.; In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.	Intra-operative	No
Secondary	Incidence of Adverse Events		30 days (+14 days)	Yes