Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds

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

Study Overview

• Status: Completed
• Conditions: Infection of Total Knee Joint Prosthesis
• Intervention / Treatment: Device: Bactisure

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • LA Orthopedic Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky Orthopedic Spine & Total Joint Service
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic & Sports Medicine Specialists
  • Ohio
    • Cleveland, Ohio, United States, 22644
      • The Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential Subjects (M and F, age 18 years or older) diagnosed with Prosthetic Joint Infection (PJI) following primary total knee (TKA) implantation, who are undergoing I & D or reoperation (revision) surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Kacy Arnold, MBA, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 22, 2018
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: infection; primary total knee
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: H.CR.I.AM.16.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No