Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Infection of Total Knee Joint Prosthesis Clinical Trial

Official title:

Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192124
• Other study ID #: H.CR.I.AM.16.10
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: January 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 22, 2019
• Est. primary completion date: December 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Infection of Total Knee Joint Prosthesis

Intervention

Device:
• Bactisure
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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio
United States	University of Kentucky Orthopedic Spine & Total Joint Service	Lexington	Kentucky
United States	LA Orthopedic Institute	Los Angeles	California
United States	Norton Orthopaedic & Sports Medicine Specialists	Louisville	Kentucky
United States	The Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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