Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Number of Patients With Wound Complications
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prevena
Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).
Intervention: Prevena (Device)
Control
A standard of care sterile wound dressing will be placed.
Outcomes
Primary Outcomes
Number of Patients With Wound Complications
Time Frame: Within 90 days after surgery
Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.
Re-operation Rates
Time Frame: 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
Time Frame: 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 Outcomes
- Knee Flexion(4 weeks postoperative)
- Hip Range of Motion(4 weeks postoperative)
- HOOS and KOOS Scores at 90 Days Postoperatively(90 days postoperative)
- Hip Range of Motion (Flexion)(4 weeks postoperative)
- Knee Extension(4 weeks postoperative)
- Timed-up-and-go Test(4 weeks postoperatively)
- VR-12 Questionnaire(90 days postoperatively)
Investigators
Carlos Higuera-Rueda
Staff, Adult Reconstruction
The Cleveland Clinic