Evaluating Bactisure Wound Lavage in Orthopedic Wounds

NCT03192124 | Completed FDA Device

• 1 other identifier: H.CR.I.AM.16.10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Infection of Total Knee Joint Prosthesis

Keywords

primary total knee; infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacteria Identification

  One Week

Interventions

Bactisure DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

LA Orthopedic Institute

Los Angeles, California, 90057, United States

Location

University of Kentucky Orthopedic Spine & Total Joint Service

Lexington, Kentucky, 40508, United States

Location

Norton Orthopaedic & Sports Medicine Specialists

Louisville, Kentucky, 40241, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 22644, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Infections

Study Officials

• Kacy Arnold, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: July 1, 2017
• Primary Completion: December 22, 2018
• Study Completion: March 22, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)