EVARREST™ Fibrin Sealant Patch Post-Market Study
Completed · Phase 4
Conditions studied: Hemorrhage, Soft Tissue Bleeding
In brief
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), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.
Key facts
- Study ID
- NCT01902459
- Run by
- Ethicon, Inc.
- People needed
- 150
- Starts
- 2013-07-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2018-01-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Clinical Site #10 — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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