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.
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 compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care. All subjects will be followed post-operatively through discharge and at 30 (+/-14) days. Approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue bleeding will be enrolled in the study. Subjects will be randomized on a 1:1 basis, EVARREST™ vs. SoC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.
Clinical Site #10
St Louis, Missouri, United States
Safety Parameter - Incidence of Thromboembolic Events
Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
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