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

Not Applicable

Completed

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

Interventions: Device: Prevena

Registration Number: NCT02127281

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevena	Prevena	Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Knee Flexion	4 weeks postoperative	Mean knee flexion (degrees) at 4 weeks postoperatively
Hip Range of Motion	4 weeks postoperative	Median hip range of motion (extension, in degrees) at 4 weeks postoperatively
HOOS and KOOS Scores at 90 Days Postoperatively	90 days postoperative	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.
Hip Range of Motion (Flexion)	4 weeks postoperative	Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively
Knee Extension	4 weeks postoperative	Median knee extension (degrees) at 4 weeks postoperatively
Timed-up-and-go Test	4 weeks postoperatively	Median Timed-up-and-go test (seconds)
VR-12 Questionnaire	90 days postoperatively	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.