Evaluation of Wound Drainage After Knee or Hip Arthroplasty

Complications; Arthroplasty Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02054936
• Other study ID #: HUM00062541
• Status: Withdrawn
• Phase: Phase 4
• First received: January 23, 2014
• Last updated: December 4, 2015
• Start date: March 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications; Arthroplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survey assessments	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	90 days	No
Primary	Number of days until a dry wound	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.	90 days	Yes
Primary	Amount and character of wound drainage	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.	90 days	No
Secondary	Number of days in the hospital postoperatively.	How many days patient is in hospital postoperatively will be noted	90 days	No
Secondary	Incidence of wound infection	Presence or absence of clinical infection will be noted according to ASEPSIS criteria.	90 days	No
Secondary	Incidence of additional operations	Additional operations include irrigation and debridement and or revision	90 days	No