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The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

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ClinicalTrials.gov Identifier: NCT00909064
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Di Cesare,MD, University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Drug: Fondaparinux Sodium (Arixtra) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Arixtra



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Days in Hospital. [ Time Frame: Up to 10 days ]
    Days after surgery to dischage

  2. Incidence of Wound Infection [ Time Frame: Up to 10 days ]
    Incidence of Cellulitis in patients undergoing Arixtra treatment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909064


Locations
United States, California
U C Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Paul Di Cesare,MD
Investigators
Principal Investigator: Paul E. DiCesare, MD University of California, Davis Health System

Responsible Party: Paul Di Cesare,MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00909064     History of Changes
Other Study ID Numbers: 200816251
GSK576428
First Posted: May 27, 2009    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2009

Additional relevant MeSH terms:
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents