The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

April 5, 2017 updated by: Paul Di Cesare,MD
The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • U C Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All primary unilateral TKA and THA cases will be included.

Exclusion Criteria:

  • Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arixtra
Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Drug: Fondaparinux Sodium (Arixtra)
2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Other Names:
  • Arixtra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days Until a Dry Wound
Time Frame: Up to 10 days
Days from day of surgery to stoppage of leakage from the wound
Up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days in Hospital.
Time Frame: Up to 10 days
Days after surgery to dischage
Up to 10 days
Incidence of Wound Infection
Time Frame: Up to 10 days
Incidence of Cellulitis in patients undergoing Arixtra treatment
Up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Di Cesare,MD

Investigators

  • Principal Investigator: Paul E. DiCesare, MD, University of California, Davis Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200816251
  • GSK576428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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