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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-01-31

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.

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Detailed Description

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Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Negative Pressure Wound Therapy (NPWT)

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT)

Intervention Type DEVICE

standard prophylactic therapy

Group Type ACTIVE_COMPARATOR

standard prophylactic therapy

Intervention Type DRUG

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

Interventions

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Negative Pressure Wound Therapy (NPWT)

Intervention Type DEVICE

standard prophylactic therapy

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

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No