The Fibrin Patch Soft Tissue Study

NCT00658723 | Completed Phase 2 Results DMC

• 1 other identifier: 400-07-002
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 11

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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Subjects Achieving Hemostatic Success

  10 minutes

• Incidence of Treatment Failures

  Intra-operative

• Incidence of Adverse Events That Are Potentially Related to Bleeding

  Intra-operative up to 1 month (+14 days)

• Incidence of Adverse Events That Are Potentially Related to Thrombotic Events

  Intra-operative up to 1 month (+14 days)

• Incidence of Adverse Events Potentially Related to Transfusion Exposure

  Intra-operative up to 1 month (+14 days)

Study Arms (2)

1

EXPERIMENTAL

Drug: Fibrin Pad

2

ACTIVE COMPARATOR

SURGICEL™ Absorbable Hemostat

Device: SURGICEL™

Interventions

Fibrin Pad DRUG

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).

1

SURGICEL™ DEVICE

Absorbable hemostat

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead
• OMRIX Biopharmaceuticals: collaborator

Study Sites (11)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Baptist Hosptial

Miami, Florida, 33173, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

St. Agnes Healthcare, Inc.

Baltimore, Maryland, 21229, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Weill Medical Colleges of Cornell University - Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 23969113 RESULT

• 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.

  PMID: 26636489 DERIVED

Results Point of Contact

• Title: Jonathan Batiller, Director Clinical Development
• Organization: ETHICON, Inc.

JBatill2@its.jnj.com

908-218-2819

Study Officials

• James Hart, M.D.

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09

Locations

US (11)