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

Mayo Clinic

Status: Withdrawn

Conditions: Total Knee Replacement Surgery; Total Hip Replacement Surgery

Treatments: Device: XPERIENCE Advanced Surgical Irrigation; Other: Standard of Care Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05577936

21-004244

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Xperience no rinse antimicrobial solution group

Experimental group

Description:

XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure

Treatment:

Device: XPERIENCE Advanced Surgical Irrigation

Normal saline solution group

Active Comparator group

Description:

Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure.

Treatment:

Other: Standard of Care Irrigation