Evaluation of Wound Drainage After Knee or Hip Arthroplasty

Phase 4

Withdrawn

• Conditions: Complications; Arthroplasty
• Interventions: Drug: Rivaroxaban (Xarelto); Drug: Warfarin (Coumadin)

• Registration Number: NCT02054936
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban (Xarelto)	Rivaroxaban (Xarelto)	Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.
Warfarin (Coumadin)	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.

Primary Outcome Measures

Name	Time	Method
Amount and character of wound drainage	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.
Number of days until a dry wound	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of wound infection	90 days	Presence or absence of clinical infection will be noted according to ASEPSIS criteria.
Number of days in the hospital postoperatively.	90 days	How many days patient is in hospital postoperatively will be noted
Incidence of additional operations	90 days	Additional operations include irrigation and debridement and or revision

Trial Locations

Locations (1)

University of Michigan Health Systems; 🇺🇸 Ann Arbor, Michigan, United States