Status:
COMPLETED
EVARREST™ Fibrin Sealant Patch Post-Market Study
Lead Sponsor:
Ethicon, Inc.
Conditions:
Hemorrhage
Soft Tissue Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area)...
Detailed Description
This is a randomized, controlled single-center study observing the clinical utility of EVARREST™ against standard of care (SoC) in controlling soft tissue bleeding. Standard of care will be manual com...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures;
- Subjects or legally authorized representative must be willing to participate in the study and provide written informed consent.
- Presence of an appropriate Target Bleeding Site as identified intra-operatively by the surgeon;
Exclusion
- Subjects with known intolerance to blood products or to one of the components of EVARREST™ or unwilling to receive blood products;
- Female subjects who are pregnant or nursing.
- TBS is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ to blood flow and/or pressure during absorption of the product;
- TBS with major arterial bleeding requiring suture or mechanical ligation;
- TBS within a contaminated or infected area of the body;
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01902459
Start Date
July 1 2013
End Date
September 1 2015
Last Update
January 17 2018
Active Locations (1)
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1
Clinical Site #10
St Louis, Missouri, United States, 63110