The Fibrin Patch Soft Tissue Study

Ethicon, Inc.141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Hemostasis

Interventions

Fibrin PadDRUG

Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

SURGICEL™DEVICE

Absorbable hemostat

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

University of Alabama

Birmingham, Alabama, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Baptist Hosptial

Miami, Florida, United States

Outcomes

Primary Outcomes

Proportion of Subjects Achieving Hemostatic Success

Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.

Time frame: Intra-operative

Secondary Outcomes

Proportion of Subjects Achieving Hemostatic Success

The proportion of subjects achieving hemostatic success at 10 minutes following randomization

Time frame: 10 minutes

Incidence of Treatment Failures

If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.

Time frame: Intra-operative

Incidence of Adverse Events That Are Potentially Related to Bleeding

The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).

Time frame: Intra-operative up to 1 month (+14 days)

Incidence of Adverse Events That Are Potentially Related to Thrombotic Events

The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism

Time frame: Intra-operative up to 1 month (+14 days)

Incidence of Adverse Events Potentially Related to Transfusion Exposure

The types of events that were potentially related to transfusion exposure could have include hypocalcemia.

Time frame: Intra-operative up to 1 month (+14 days)

Incidence of Re-treatment

Data from ClinicalTrials.gov

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