Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854138
• Other study ID #: KCI-1333
• Secondary ID: IRB#13-033
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: ProMedica Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection of Total Hip Joint Prosthesis

Intervention

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.

Locations

Country	Name	City	State
United States	Wildwood Orthopaedic and Spine Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ProMedica Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hospital Readmissions		60 days
Secondary	Number of Participants With Infection		60 days
Secondary	Number of Participants With Seroma		60 days
Secondary	Number of Participants With Hematoma		60 days