Evaluating Bactisure Wound Lavage in Orthopedic Wounds

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Primary Outcome Measures:
Secondary Outcome Measures:

  • Bacteria Identification [ Time Frame: One Week ]

    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.

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.

This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. 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.