Evaluating Bactisure Wound Lavage in Orthopedic Wounds
Completed
Conditions studied: Infection of Total Knee Joint Prosthesis
In brief
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
Key facts
- Study ID
- NCT03192124
- Run by
- Zimmer Biomet
- People needed
- 40
- Starts
- 2017-07-01
- Expected to finish
- 2019-03-22
- Last updated by the study team
- 2020-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- LA Orthopedic Institute — Los Angeles, California, United States
- University of Kentucky Orthopedic Spine & Total Joint Service — Lexington, Kentucky, United States
- Norton Orthopaedic & Sports Medicine Specialists — Louisville, Kentucky, United States
- The Cleveland Clinic — Cleveland, Ohio, United States
- The Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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