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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of the Next Science® XPERIENCE™ Advanced Surgical Irrigation Versus Standard of Care Irrigation Efficacy in Decreasing Bioburden in Primary Total Hip and Knee Arthroplasty Wounds

Conditions
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Total Knee Replacement Surgery, Total Hip Replacement Surgery

Intervention / Treatment
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* Device: XPERIENCE Advanced Surgical Irrigation
* Other: Standard of Care Irrigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xperience no rinse antimicrobial solution group<br>XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure | Device: XPERIENCE Advanced Surgical Irrigation<br>* 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<br>|
| Active Comparator: Normal saline solution group<br>Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure. | Other: Standard of Care Irrigation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in culture positive rates | Number of culture positive tissue samples | Baseline (pre-irrigation) and post-irrigation approximately 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Periprosthetic Joint Infection | Number of subjects to have deep periprosthetic joint infection within 90 days of index operation | 90 days |