Clinical trial NCT02127281: Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
Official title: Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis-related Infections
Wound Complications
Joint Diseases
Musculoskeletal Diseases
Keywords: Revision total knee arthroplasty
Revision total hip arthroplasty
Negative pressure wound therapy system (NPWT)
Drainage
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2014-04-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of Patients With Wound Complications
timeFrame: Within 90 days after surgery
measure: Re-operation Rates
timeFrame: Within 90 days after surgery
measure: Readmission Rates
timeFrame: Within 90 days after surgery
Secondary outcomes:
measure: Knee Flexion
timeFrame: 4 weeks postoperative
measure: HOOS and KOOS Scores at 90 Days Postoperatively
timeFrame: 90 days postoperative
measure: Timed-up-and-go Test
timeFrame: 4 weeks postoperatively
measure: Hip Range of Motion (Flexion)
timeFrame: 4 weeks postoperative
measure: VR-12 Questionnaire
timeFrame: 90 days postoperatively
measure: Hip Range of Motion
timeFrame: 4 weeks postoperative
measure: Knee Extension
timeFrame: 4 weeks postoperative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Carlos Higuera-Rueda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.
citation: Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.