A Non-Investigational Post-Market Trial Using EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ethicon, Inc.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Safety Parameter - Incidence of Thromboembolic Events
Study Overview
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), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
EVARREST™ Fibrin Sealant Patch
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.
Intervention: EVARREST™ Fibrin Sealant Patch (Biological)
Standard of Care
Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Safety Parameter - Incidence of Thromboembolic Events
Time Frame: Surgery up until the 30 day follow-up
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.
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
Time Frame: Surgery up until the 30 day follow-up
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.
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
Time Frame: Surgery up until the 30 day follow-up
Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Secondary Outcomes
No secondary outcomes reported