Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy (NPWT)
* Drug: standard prophylactic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages: 18 to 80 Males- not involved in active military duty. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Exclusion Criteria: Active systemic or local infection. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin) Active autoimmune disease. Any past or present immunosuppressive treatment. Current treatment with chemotherapeutic agents History of metabolic bone disease (primary or secondary). Chronic renal insufficiency (defined by 50% increase of normal levels).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy (NPWT)<br> | Device: Negative Pressure Wound Therapy (NPWT)<br> <br> |
| Active Comparator: standard prophylactic therapy<br> | Drug: standard prophylactic therapy<br>* administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks | The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To assess the proportion on infections at two weeks and 6 weeks of follow-up. | To assess the proportion on infections at two weeks and 6 weeks of follow-up. | two weeks and six weeks | 
| The number of patients recommended to undergo further procedural intervention because of the infection. | The number of patients recommended to undergo further procedural intervention because of the infection. | 12 MONTHS |