Evaluation of Wound Drainage After Knee or Hip Arthroplasty

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Andrew Urquhart, University of Michigan
ClinicalTrials.gov Identifier:
NCT02054936
First received: January 23, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    How many days patient is in hospital postoperatively will be noted

  • Incidence of wound infection [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Presence or absence of clinical infection will be noted according to ASEPSIS criteria.

  • Incidence of additional operations [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Additional operations include irrigation and debridement and or revision


Other Outcome Measures:
  • Survey assessments [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054936

Contacts
Contact: Mary M Groll-Brown, BS 734-763-5442 brmary@umich.edu

Locations
United States, Michigan
University of Michigan Health Systems Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mary M Groll-Brown, BS    734-763-5442      
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Andrew G Urquhart, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Andrew Urquhart, M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement, University of Michigan
ClinicalTrials.gov Identifier: NCT02054936     History of Changes
Other Study ID Numbers: HUM00062541
Study First Received: January 23, 2014
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Rivaroxaban
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014