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Evaluating Bactisure Wound Lavage in Orthopedic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192124
Recruitment Status : Active, not recruiting
First Posted : June 19, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Infection of Total Knee Joint Prosthesis Device: Bactisure

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 22, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Reduction WBC [ Time Frame: Intraoperative ]
    To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage


Secondary Outcome Measures :
  1. Bacteria Identification [ Time Frame: One Week ]
    To quantitatively and qualitatively assess the synovial fluid for the presence of bacteria prior to and after lavage. This testing will compare the microbial population (species) of the surgical wounds by serial culture dilution, and bacterial identification by PCR before and after irrigation.


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192124


Locations
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United States, California
LA Orthopedic Institute
Los Angeles, California, United States, 90057
United States, Kentucky
University of Kentucky Orthopedic Spine & Total Joint Service
Lexington, Kentucky, United States, 40508
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, United States, 40241
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 22644
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Bill Bourdeau Zimmer Biomet

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03192124     History of Changes
Other Study ID Numbers: H.CR.I.AM.16.10
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zimmer Biomet:
primary total knee
infection