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The Fibrin Patch Soft Tissue Study

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ClinicalTrials.gov Identifier: NCT00658723
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hemostasis Drug: Fibrin Pad Device: SURGICEL™ Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

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




Primary Outcome Measures :
  1. Proportion of Subjects Achieving Hemostatic Success [ Time Frame: Intra-operative ]
    Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.


Secondary Outcome Measures :
  1. Proportion of Subjects Achieving Hemostatic Success [ Time Frame: 10 minutes ]
    The proportion of subjects achieving hemostatic success at 10 minutes following randomization

  2. Incidence of Treatment Failures [ Time Frame: Intra-operative ]
    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.

  3. Incidence of Adverse Events That Are Potentially Related to Bleeding [ Time Frame: Intra-operative up to 1 month (+14 days) ]
    The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).

  4. Incidence of Adverse Events That Are Potentially Related to Thrombotic Events [ Time Frame: Intra-operative up to 1 month (+14 days) ]
    The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism

  5. Incidence of Adverse Events Potentially Related to Transfusion Exposure [ Time Frame: Intra-operative up to 1 month (+14 days) ]
    The types of events that were potentially related to transfusion exposure could have include hypocalcemia.

  6. Incidence of Re-treatment [ Time Frame: Intra-operative ]

    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.


  7. Incidence of Adverse Events [ Time Frame: 30 days (+14 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658723


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Baptist Hosptial
Miami, Florida, United States, 33173
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
St. Agnes Healthcare, Inc.
Baltimore, Maryland, United States, 21229
United States, New York
Long Island Jewish Medical Center
NEw Hyde Park, New York, United States, 11040
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Weill Medical Colleges of Cornell University - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals
Investigators
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Study Director: James Hart, M.D. Ethicon, Inc.