Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

NCT ID: NCT01854138

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Infection of Total Hip Joint Prosthesis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Prevena Incision Management System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

negative pressure wound therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProMedica Health System

OTHER

Sponsor Role: lead

Responsible Party

Karl Beer

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Beer, MD

Role: PRINCIPAL_INVESTIGATOR

ProMedica Health System

Locations

Wildwood Orthopaedic and Spine Hospital

Toledo, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28705547 (View on PubMed)

Other Identifiers

IRB#13-033

Identifier Type: OTHER

Identifier Source: secondary_id

KCI-1333

Identifier Type: -

Identifier Source: org_study_id