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Completed

NCT Number: NCT01854138

Evaluating Advantages of Prevena After Hip and Knee 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wildwood Orthopaedic and Spine Hospital

Toledo, Ohio, 43615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevena Incision Management System

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.

Other names: negative pressure wound therapy

Primary outcomes

  1. Number of Participants With Hospital Readmissions

    Time frame: 60 days

Secondary outcomes

  1. Number of Participants With Infection

    Time frame: 60 days

  2. Number of Participants With Seroma

    Time frame: 60 days

  3. Number of Participants With Hematoma

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Official study title

Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2013
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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