EVARREST™ Fibrin Sealant Patch Post-Market Study

Ethicon

Status and phase

Completed

Phase 4

Conditions

Soft Tissue Bleeding

Hemorrhage

Treatments

Biological: EVARREST™ Fibrin Sealant Patch

Other: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01902459

400-12-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;