Clinical trial NCT03192124: Evaluating Bactisure Wound Lavage in Orthopedic Wounds
Official title: Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection of Total Knee Joint Prosthesis
Keywords: primary total knee
infection
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction WBC
timeFrame: Intraoperative
Secondary outcomes:
measure: Bacteria Identification
timeFrame: One Week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA Orthopedic Institute
state: California
city: Lexington
country: United States
facility: University of Kentucky Orthopedic Spine & Total Joint Service
state: Kentucky
city: Louisville
country: United States
facility: Norton Orthopaedic & Sports Medicine Specialists
state: Kentucky
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, MBA
role: STUDY_DIRECTOR
References: