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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hemostasis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of subjects achieving hemostatic success

Outcome Time Frame:

Intra-operative

Safety Issue:

No

Principal Investigator

James Hart, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ethicon, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

400-07-002

NCT ID:

NCT00658723

Start Date:

March 2008

Completion Date:

May 2009

Related Keywords:

  • Hemostasis

Name

Location

University of AlabamaBirmingham, Alabama  
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Medical College of GeorgiaAugusta, Georgia  30912
St. Agnes Healthcare, Inc.Baltimore, Maryland  21229-5299
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Emory University HospitalAtlanta, Georgia  30322
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Baptist HosptialMiami, Florida  33173
Weill Medical Colleges of Cornell University - Methodist HospitalHouston, Texas  77030