Evaluating Bactisure Wound Lavage in Orthopedic Wounds
United States40 participantsStarted 2017-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.