Cleveland Clinic
Cleveland, Ohio, 440195, United States
NCT Number: NCT02127281
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 440195, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device will be applied at end of procedure over closed incision.
Time frame: Within 90 days after surgery
Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.
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
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
Time frame: 4 weeks postoperative
Mean knee flexion (degrees) at 4 weeks postoperatively
Time frame: 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.
Time frame: 4 weeks postoperatively
Median Timed-up-and-go test (seconds)
Time frame: 4 weeks postoperative
Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively
Time frame: 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.
Time frame: 4 weeks postoperative
Median hip range of motion (extension, in degrees) at 4 weeks postoperatively
Time frame: 4 weeks postoperative
Median knee extension (degrees) at 4 weeks postoperatively
The Cleveland Clinic
Other
Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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