Infection of Total Hip Joint Prosthesis Clinical Trial
Official title:
Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty
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.
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.
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