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

Hadassah Medical Organization

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Total Knee Replacement

Interventions

Negative Pressure Wound Therapy (NPWT)DEVICE

standard prophylactic therapyDRUG

administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks

Time frame: six weeks

Secondary Outcomes

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.

Time frame: two weeks and six weeks

The number of patients recommended to undergo further procedural intervention because of the infection.

Time frame: 12 MONTHS

Data from ClinicalTrials.gov

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