Evaluation of Wound Drainage After Knee or Hip Arthroplasty

Phase 4WithdrawnNCT02054936

University of Michigan

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Complications; Arthroplasty

Interventions

Rivaroxaban (Xarelto)DRUG

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)DRUG

To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 days

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.

Time frame: 90 days

Secondary Outcomes

Number of days in the hospital postoperatively.

How many days patient is in hospital postoperatively will be noted

Time frame: 90 days

Incidence of wound infection

Presence or absence of clinical infection will be noted according to ASEPSIS criteria.

Time frame: 90 days

Incidence of additional operations

Additional operations include irrigation and debridement and or revision

Time frame: 90 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.