N/A
N=160
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
Prosthesis-related Infections · Wound Complications · Joint Diseases · Musculoskeletal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02127281 ↗Enrolled (actual)
160
Serious AEs
35.6%
Results posted
Mar 2018
Primary outcome: Primary: Number of Patients With Wound Complications — 9; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Wound Complications |
9; 22 | — |
| PRIMARY Re-operation Rates |
5; 11 | — |
| PRIMARY Readmission Rates |
16; 16 | — |
| SECONDARY Knee Flexion |
89.7; 88.9 | — |
| SECONDARY HOOS and KOOS Scores at 90 Days Postoperatively |
18.8; 21.9; 43.8; 34.4; 0; 10 | — |
| SECONDARY Timed-up-and-go Test |
25; 24.2 | — |
| SECONDARY Hip Range of Motion (Flexion) |
73.6; 75.3 | — |
| SECONDARY VR-12 Questionnaire |
33.3; 31.5; 50.2; 46.6 | — |
| SECONDARY Hip Range of Motion |
5; 0 | — |
| SECONDARY Knee Extension |
5; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02127281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.