Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty

Not Applicable

Withdrawn

• Conditions: Total Knee Replacement Surgery; Total Hip Replacement Surgery
• Interventions: Device: XPERIENCE Advanced Surgical Irrigation; Other: Standard of Care Irrigation

• Registration Number: NCT05577936
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to evaluate the effectiveness of Xperience, a no rinse antimicrobial solution, on joint infection rates in patients undergoing total hip (THA) and total knee (TKA) arthoplasty surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-13
• Study Start: 2023-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
• Willing to comply with all study-related procedures and be available for the duration of the study.
• Provide signed and dated informed consent.

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Exclusion Criteria

• Unable to provide signed and dated informed consent.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xperience no rinse antimicrobial solution group	XPERIENCE Advanced Surgical Irrigation	XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure
Normal saline solution group	Standard of Care Irrigation	Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure.

Primary Outcome Measures

Name	Time	Method
Change in culture positive rates	Baseline (pre-irrigation) and post-irrigation approximately 3 minutes	Number of culture positive tissue samples

Secondary Outcome Measures

Name	Time	Method
Deep Periprosthetic Joint Infection	90 days	Number of subjects to have deep periprosthetic joint infection within 90 days of index operation

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States