Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Completed

• Conditions: Infection of Total Knee Joint Prosthesis

• Registration Number: NCT03192124
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2017-07-01
• Primary Completion: 2018-12-22
• Study Completion: 2019-03-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bacteria Identification	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.

Trial Locations

Locations (5)

Norton Orthopaedic & Sports Medicine Specialists; 🇺🇸 Louisville, Kentucky, United States

LA Orthopedic Institute; 🇺🇸 Los Angeles, California, United States

University of Kentucky Orthopedic Spine & Total Joint Service; 🇺🇸 Lexington, Kentucky, United States

The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States