Clinical trial NCT01854138: Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
Official title: Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection of Total Hip Joint Prosthesis
Keywords: primary knee arthroplasty
primary hip arthroplasty
negative pressure wound therapy
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Hospital Readmissions
timeFrame: 60 days
Secondary outcomes:
measure: Number of Participants With Infection
timeFrame: 60 days
measure: Number of Participants With Seroma
timeFrame: 60 days
measure: Number of Participants With Hematoma
timeFrame: 60 days
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Wildwood Orthopaedic and Spine Hospital
state: Ohio
Study officials:
affiliation: ProMedica Health System
name: Karl Beer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17.