The Severe Soft Tissue Bleeding Study

Ethicon

Status and phase

Completed

Phase 3

Conditions

Soft Tissue Bleeding

Treatments

Biological: Fibrin Pad

Procedure: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT00977925

400-08-002

Details and patient eligibility

About

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects >= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
Presence of an appropriate severe bleeding soft tissue Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
Subjects must be willing to participate in the study, and provide written informed consent.

Exclusion criteria

Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
Bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product;
Subject with TBS within an actively infected field;
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
Subjects with known intolerance to blood products or to one of the components of the study product;
Subjects unwilling to receive blood products;
Subjects with known immunodeficiency diseases (including known HIV);
Subjects who are known, current alcohol and / or drug abusers;
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment;
Female subjects who are pregnant or nursing.