The Fibrin Patch Soft Tissue Study

Ethicon

Status and phase

Completed

Phase 2

Conditions

Hemostasis

Treatments

Device: SURGICEL™

Drug: Fibrin Pad

Study type

Interventional

Funder types

Industry

Identifiers

NCT00658723

400-07-002

Details and patient eligibility

About

The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Enrollment

141 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively 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
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 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