Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Launched by ZIMMER BIOMET · Jun 15, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.