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The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

NCT00990288 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2017-12-12

Study results available
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Summary

The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

Conditions

  • Blood Loss

Interventions

DRUG

Hemostatic Matrix

FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Mark P Figgie, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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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 NCT00990288 on ClinicalTrials.gov