The Fibrin Patch Soft Tissue Study

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

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.

Study Overview

• Status: Completed
• Conditions: Hemostasis
• Intervention / Treatment: Drug: Fibrin Pad; Device: SURGICEL™

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33173
      • Baptist Hosptial
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Healthcare, Inc.
  • New York
    • NEw Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Weill Medical Colleges of Cornell University - Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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).
Active Comparator: 2; SURGICEL™ Absorbable Hemostat	Device: SURGICEL™; Absorbable hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving Hemostatic Success	The proportion of subjects achieving hemostatic success at 10 minutes following randomization	10 minutes
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
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)
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)
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)
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
Incidence of Adverse Events		30 days (+14 days)

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Collaborators: OMRIX Biopharmaceuticals
• Investigators: Study Director: James Hart, M.D., Ethicon, Inc.

Publications and helpful links

General Publications

• 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 surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036.
• Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 11, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 400-07-002