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Evaluation of Wound Drainage After Knee or Hip Arthroplasty

This study has been withdrawn prior to enrollment.
(Change in standard of care, no possibility of recruitment)
Information provided by (Responsible Party):
Andrew Urquhart, University of Michigan Identifier:
First received: January 23, 2014
Last updated: December 4, 2015
Last verified: December 2015
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 Intervention Phase
Complications; Arthroplasty
Drug: Rivaroxaban (Xarelto)
Drug: Warfarin (Coumadin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.

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

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

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

Other Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT02054936

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

Responsible Party: Andrew Urquhart, M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement, University of Michigan Identifier: NCT02054936     History of Changes
Other Study ID Numbers: HUM00062541
Study First Received: January 23, 2014
Last Updated: December 4, 2015

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on April 28, 2017