CompletedNot Applicable

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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction WBC

Timeframe: Intraoperative

Trial details

NCT IDNCT03192124

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-12-22

View on ClinicalTrials.gov More Infection of Total Knee Joint Prosthesis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.