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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 : Completed
First Posted : June 19, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date June 15, 2017
First Posted Date June 19, 2017
Last Update Posted Date January 27, 2020
Actual Study Start Date July 1, 2017
Actual Primary Completion Date December 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Bactisure Wound Lavage in Orthopedic Wounds
Official Title Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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
Condition Infection of Total Knee Joint Prosthesis
Intervention 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2017)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date March 22, 2019
Actual Primary Completion Date December 22, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03192124
Other Study ID Numbers H.CR.I.AM.16.10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Zimmer Biomet
Original Responsible Party Same as current
Current Study Sponsor Zimmer Biomet
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold, MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date January 2020