MedTrace Logo

The Fibrin Patch Soft Tissue Study

NCT00658723 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2014-09-11

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Hemostasis

Interventions

DRUG

Fibrin Pad

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).

DEVICE

SURGICEL™

Absorbable hemostat

Sponsors & Collaborators

  • OMRIX Biopharmaceuticals

    collaborator INDUSTRY

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • James Hart, M.D. · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658723 on ClinicalTrials.gov