Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Study Overview
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Brief Summary
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To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.

Detailed Description
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This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage. This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I & D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.

Official Title
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Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds

Conditions
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Infection of Total Knee Joint Prosthesis

Intervention / Treatment
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* Device: Bactisure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing I & D or reoperation (revision) surgery for an infected primary TKA. Patient is 18 years of age or greater. Patient is skeletally mature. Occurs within 30 days of the operation or within 1 year or more if an implant is present Involves deep soft tissues (e.g., fascia and/or muscle) of the incision Patient is willing and able to provide written informed consent. Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol Exclusion Criteria: Patients will be excluded from this study if: Patient is unwilling or unable to give consent or to comply with the follow-up program. Known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution Multiple (>1) infected implants Medically unfit for irrigation & debridement procedure Pregnancy The patient is: prisoner mentally incompetent or unable to understand what participation in the study entails anticipated to be non-compliant.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bactisure|Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin. Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction WBC | To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteria Identification | To quantitatively and qualitatively assess the synovial fluid for the presence of bacteria prior to and after lavage. This testing will compare the microbial population (species) of the surgical wounds by serial culture dilution, and bacterial identification by PCR before and after irrigation. | One Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary total knee, infection