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Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

NCT01410240 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2014-06-06

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.

Conditions

Interventions

PROCEDURE

Standard of Care

Conventional hemostatic techniques, such as cautery and manual compression, will be used.

DRUG

FLOSEAL Hemostatic Matrix + Standard of care

FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes. \+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Ildiko Szabo, MD, MBA · Baxter Innovations GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01410240 on ClinicalTrials.gov