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Evaluation of Wound Drainage After Knee or Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02054936
Recruitment Status : Withdrawn (Change in standard of care, no possibility of recruitment)
First Posted : February 4, 2014
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
Andrew Urquhart, University of Michigan

Brief Summary:
To compare side effects and complications relating to use of warfarin or rivaroxaban, tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively, extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two randomized groups. Return visits to the operating room, length of stay, and VTE rates will also be compared.

Condition or disease Intervention/treatment Phase
Complications; Arthroplasty Drug: Rivaroxaban (Xarelto) Drug: Warfarin (Coumadin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Wound Drainage Following Rivaroxaban (Xarelto) or Warfarin (Coumadin) for Post op Venous Thromboembolism (VTE) Prophylaxis, After Knee or Hip Arthroplasty a Randomized Study.
Study Start Date : March 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Rivaroxaban (Xarelto)
Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.
Drug: Rivaroxaban (Xarelto)
To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Active Comparator: Warfarin (Coumadin)
Warfarin dosing will be titrated to achieve an INR of 2-3 and dosing will begin on postoperative day 1 for a duration of 30 days.
Drug: Warfarin (Coumadin)
To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Primary Outcome Measures :
  1. Number of days until a dry wound [ Time Frame: 90 days ]
    Comparative wound oozing time between patients receiving Rivaroxaban and those receiving Warfarin will be measured. Wound will be defined as actively draining if the gauze covering the wound is wet to the edges or if fluid is noted to be originating from the surgical site. The nursing staff will record the wound drainage during the hospital stay and the patient will be instructed in self assessment upon discharge using the patient diary.Wound drainage will be recorded twice daily. Time when the wound appeared dry will be noted.

  2. Amount and character of wound drainage [ Time Frame: 90 days ]
    Wound assessments, including photographs, will occur by a research team member blinided to the anticoagulant being used at three set points; 2 days, 2 weeks, and 6 weeks postoperatively.

Secondary Outcome Measures :
  1. Number of days in the hospital postoperatively. [ Time Frame: 90 days ]
    How many days patient is in hospital postoperatively will be noted

  2. Incidence of wound infection [ Time Frame: 90 days ]
    Presence or absence of clinical infection will be noted according to ASEPSIS criteria.

  3. Incidence of additional operations [ Time Frame: 90 days ]
    Additional operations include irrigation and debridement and or revision

Other Outcome Measures:
  1. Survey assessments [ Time Frame: 90 days ]
    Satisfaction and activity combined scores from the UCLA Activity Score and the PROMIS Survey at 90 days will be compared to UCLA Activity Score and PROMIS Survey at preoperative visit

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.

Exclusion Criteria:

  • Patients with a contraindication to pharmacologic VTE prophylaxis such as hemophilia, Plavix use, active bleeding or prior reaction to warfarin or rivaroxaban, nursing mothers, hepatic disease, GFR <30, use of more than 200mg of aspirin daily, and inability to continue medication or lab monitoring after hospital discharge known preoperatively.

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 identifier (NCT number): NCT02054936

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United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Andrew G Urquhart, M.D. University of Michigan

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Responsible Party: Andrew Urquhart, M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement, University of Michigan Identifier: NCT02054936    
Other Study ID Numbers: HUM00062541
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action