Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
Condition: Infection of Total Hip Joint Prosthesis
Study type: Interventional

Summary: 
      Determine the extent to which application of the Prevena vacuum system to clean surgical
      incisions immediately following surgical procedure (total hip or total knee arthroplasty)
      will reduce the rates of:

        -  readmission to hospital for surgical intervention due to wound complications

        -  seroma

        -  hematoma

        -  infection compared to group of patients whose wounds were covered with traditional gauze
           dressings.
    

Detailed description: 
      The specific aim of this research project is to determine the effect of using the Prevena
      vacuum system on the rate of repeat surgical procedures and surgical site complications in
      patients having undergone a total knee or hip arthroplasty. It is believed that negative
      pressure wound therapy is effective in the promotion of healing of complicated, non-healing,
      and infected wounds in many settings. In light of this existing evidence, the investigators
      believe that applying negative pressure wound therapy to clean incisions, in the orthopedic
      setting, before infection or complication occur may prevent complications and lower overall
      cost of care for patients undergoing total hip or knee arthroplasty.

      The investigators' primary hypothesis is that application of the Prevena vacuum system to a
      clean incision in the operating room for patients who have undergone a total knee
      arthroplasty or hip replacement surgery will reduce the occurrence of repeat surgeries when
      the system remains in place and functional for seven days following its application. Prevena
      is the ideal system for this patient population because it is best suited for non-draining
      wounds; hip and knee arthroplasties result most often in non-draining wounds, which evidence
      suggests are less likely to become infected and cause other complications.

      Secondary hypotheses to be tested in this study are that the application and use of the
      Prevena vacuum system in patients who have undergone a total knee arthroplasty or hip
      replacement surgery will reduce the occurrence of seromas, hematomas, and will also reduce
      the occurrence of surgical site infections when the system remains in place and functional
      for seven days after application. Additionally, the investigators wish to compare the level
      of pain experienced by patients who use the Prevena system after surgery in comparison to
      those whose incision sites are covered with traditional dressings. The investigators
      hypothesize that patients whose wounds are dressed with the Prevena system will experience
      less pain than patients whose wounds are dressed with traditional dressings, which may be
      quite bulky and carry the risk of tape trauma injury. Finally, the investigators hypothesize
      that because the Prevena system will prevent surgical site complications that may lead to
      repeat procedures, the cost of treating patients with Prevena will be lower than the total
      relative cost of treating the patients whose wounds are dressed with traditional dressings.
    

Intervention name(s): Prevena Incision Management System
Intervention type(s): Device
Intervention description(s): Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Other intervention name(s): negative pressure wound therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: primary knee arthroplasty; primary hip arthroplasty; negative pressure wound therapy