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Completed

NCT Number: NCT02127281

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 440195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevena

Device

Device will be applied at end of procedure over closed incision.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Knee Flexion

    Time frame: 4 weeks postoperative

    Mean knee flexion (degrees) at 4 weeks postoperatively

  2. HOOS and KOOS Scores at 90 Days 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.

  3. Timed-up-and-go Test

    Time frame: 4 weeks postoperatively

    Median Timed-up-and-go test (seconds)

  4. Hip Range of Motion (Flexion)

    Time frame: 4 weeks postoperative

    Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively

  5. VR-12 Questionnaire

    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.

  6. Hip Range of Motion

    Time frame: 4 weeks postoperative

    Median hip range of motion (extension, in degrees) at 4 weeks postoperatively

  7. Knee Extension

    Time frame: 4 weeks postoperative

    Median knee extension (degrees) at 4 weeks postoperatively

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • KCI USA, Inc

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2014
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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