Evaluating Bactisure Wound Lavage in Or… | Clinical Trial

Key information

Conditions

Infection of Total Knee Joint Prosthesis Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LA Orthopedic Institute, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Reduction WBC

Time frame: 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 outcomes

Bacteria Identification

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Jun 19, 2017
Registry last updated: Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed