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

Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.

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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Musculoskeletal Diseases; Prosthesis-related Infections; Wound Complications
• Intervention / Treatment: Device: Prevena

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 440195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Prevena; Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).	Device: Prevena; Device will be applied at end of procedure over closed incision.
NO_INTERVENTION: Control; A standard of care sterile wound dressing will be placed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: 3M
• Investigators: Principal Investigator: Carlos Higuera-Rueda, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): April 24, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (ESTIMATE): April 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Drainage; Revision total knee arthroplasty; Revision total hip arthroplasty; Negative pressure wound therapy system (NPWT)
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Prosthesis-Related Infections
• Other Study ID Numbers: CCF 14-273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO