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Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01854138
First Posted: May 15, 2013
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karl Beer, ProMedica Health System
May 12, 2013
May 15, 2013
May 6, 2015
January 2014
March 2015   (Final data collection date for primary outcome measure)
hospital readmission [ Time Frame: 60 days ]
Same as current
Complete list of historical versions of study NCT01854138 on ClinicalTrials.gov Archive Site
  • infection [ Time Frame: 60 days ]
  • seroma incidence [ Time Frame: 60 days ]
  • hematoma formation [ Time Frame: 60 days ]
Same as current
Not Provided
Not Provided
 
Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infection of Total Hip Joint Prosthesis
Device: Prevena Incision Management System

Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.

Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.

Other Name: negative pressure wound therapy
  • 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
    Prospectively enrolled patients undergoing Total Knee Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.
    Intervention: Device: Prevena Incision Management System
  • Experimental: Prevena Hip
    Prospectively enrolled patients undergoing Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.
    Intervention: Device: Prevena Incision Management System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing primary total hip or knee arthroplasty
  • 18-85 years of age

Exclusion Criteria:

  • Patients undergoing revision total hip or knee arthroplasty
  • Allergy to silver
  • Current systemic infection
  • Currently being treated for malignancy
  • Patients suffering from anemia or malnutrition
  • Patients afflicted with jaundice
  • Patients deemed to be non-compliant
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01854138
KCI-1333
IRB#13-033 ( Other Identifier: ProMedica Institutional Review Board )
No
Not Provided
Not Provided
Karl Beer, ProMedica Health System
ProMedica Health System
Not Provided
Principal Investigator: Karl Beer, MD ProMedica Health System
ProMedica Health System
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP