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Evaluating Bactisure Wound Lavage in Orthopedic Wounds

NCT03192124 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-01-27

No results posted yet for this study

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.

Conditions

  • Infection of Total Knee Joint Prosthesis

Interventions

DEVICE

Bactisure

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Kacy Arnold, MBA · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-12-22
Completion
2019-03-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192124 on ClinicalTrials.gov