Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Zimmer Biomet

Status: Completed

Conditions: Infection of Total Knee Joint Prosthesis

Treatments: Device: Bactisure

Study type: Observational

Funder types: Industry

Identifiers

NCT03192124

H.CR.I.AM.16.10

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.