Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01854138|
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
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
- infection compared to group of patients whose wounds were covered with traditional gauze dressings.
|Condition or disease||Intervention/treatment||Phase|
|Infection of Total Hip Joint Prosthesis||Device: Prevena Incision Management System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||April 2015|
No Intervention: Control
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
Experimental: Prevena Knee/Hip
Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.
Device: Prevena Incision Management System
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 Name: negative pressure wound therapy
- Number of Participants With Hospital Readmissions [ Time Frame: 60 days ]
- Number of Participants With Infection [ Time Frame: 60 days ]
- Number of Participants With Seroma [ Time Frame: 60 days ]
- Number of Participants With Hematoma [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854138
|United States, Ohio|
|Wildwood Orthopaedic and Spine Hospital|
|Toledo, Ohio, United States, 43615|
|Principal Investigator:||Karl Beer, MD||ProMedica Health System|