Clinical trial NCT00658723: The Fibrin Patch Soft Tissue Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2008-04-15
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of Subjects Achieving Hemostatic Success
timeFrame: Intra-operative
Secondary outcomes:
measure: Proportion of Subjects Achieving Hemostatic Success
timeFrame: 10 minutes
measure: Incidence of Treatment Failures
timeFrame: Intra-operative
measure: Incidence of Adverse Events That Are Potentially Related to Bleeding
timeFrame: Intra-operative up to 1 month (+14 days)
measure: Incidence of Adverse Events That Are Potentially Related to Thrombotic Events
timeFrame: Intra-operative up to 1 month (+14 days)
measure: Incidence of Adverse Events Potentially Related to Transfusion Exposure
timeFrame: Intra-operative up to 1 month (+14 days)
measure: Incidence of Re-treatment
timeFrame: Intra-operative
measure: Incidence of Adverse Events
timeFrame: 30 days (+14 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Baptist Hosptial
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Healthcare, Inc.
state: Maryland
city: NEw Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Weill Medical Colleges of Cornell University - Methodist Hospital
state: Texas
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.