Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty
NCT ID: NCT05577936
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-03-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Xperience no rinse antimicrobial solution group
XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure
XPERIENCE Advanced Surgical Irrigation
A clear, colorless, aqueous solution that is indicated for use in the cleansing and removal of debris, including microorganisms, from wounds. Soak for 3 minutes for a total volume of 1L
Normal saline solution group
Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure.
Standard of Care Irrigation
17.5 mL povidone-iodine with 500 mL normal saline: solution (0.35%) for 3 minutes for a total volume of 1L (including a normal saline rinse)
Interventions
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XPERIENCE Advanced Surgical Irrigation
A clear, colorless, aqueous solution that is indicated for use in the cleansing and removal of debris, including microorganisms, from wounds. Soak for 3 minutes for a total volume of 1L
Standard of Care Irrigation
17.5 mL povidone-iodine with 500 mL normal saline: solution (0.35%) for 3 minutes for a total volume of 1L (including a normal saline rinse)
Eligibility Criteria
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Inclusion Criteria
* Willing to comply with all study-related procedures and be available for the duration of the study.
* Provide signed and dated informed consent.
Exclusion Criteria
* Unwilling or unable to comply with all study-related procedures.
* Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
* Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
* Pregnant, planning to become pregnant, or nursing female subjects.
* Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
* Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
* Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Cameron K. Ledford
Principal Investigator
Principal Investigators
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Cameron Ledford, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-004244
Identifier Type: -
Identifier Source: org_study_id
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