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Delay in funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xperience no rinse antimicrobial solution group | Experimental | XPERIENCE Advanced Surgical Irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure |
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| Normal saline solution group | Active Comparator | Standard of care irrigation will be utilized as the final wash after the TKA or THA procedure prior to closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPERIENCE Advanced Surgical Irrigation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in culture positive rates | Number of culture positive tissue samples | Baseline (pre-irrigation) and post-irrigation approximately 3 minutes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cameron Ledford, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Standard of Care Irrigation | Other | 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) |
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