Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.

Detailed Description
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One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).

Official Title
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Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.

Conditions
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Prosthesis-related Infections, Wound Complications, Joint Diseases, Musculoskeletal Diseases

Intervention / Treatment
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* Device: Prevena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled revision Total Hip or Knee Arthroplasty Procedure Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV. Exclusion Criteria: Patient lives >100 miles from hospital Patient is < 18 years old Silver allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevena<br>Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). | Device: Prevena<br>* Device will be applied at end of procedure over closed incision.<br>|
| No Intervention: Control<br>A standard of care sterile wound dressing will be placed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Wound Complications | Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection. | Within 90 days after surgery | 
| Re-operation Rates | Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision | Within 90 days after surgery | 
| Readmission Rates | Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision | Within 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Flexion | Mean knee flexion (degrees) at 4 weeks postoperatively | 4 weeks postoperative | 
| HOOS and KOOS Scores at 90 Days Postoperatively | Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score. | 90 days postoperative | 
| Timed-up-and-go Test | Median Timed-up-and-go test (seconds) | 4 weeks postoperatively | 
| Hip Range of Motion (Flexion) | Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively | 4 weeks postoperative | 
| VR-12 Questionnaire | Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively. | 90 days postoperatively | 
| Hip Range of Motion | Median hip range of motion (extension, in degrees) at 4 weeks postoperatively | 4 weeks postoperative | 
| Knee Extension | Median knee extension (degrees) at 4 weeks postoperatively | 4 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision total knee arthroplasty, Revision total hip arthroplasty, Negative pressure wound therapy system (NPWT), Drainage