Total Hip Replacement Surgery, Total Knee Replacement Surgery
Conditions
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.
Interventions
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
OTHERStandard 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)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in culture positive rates | Baseline (pre-irrigation) and post-irrigation approximately 3 minutes | Number of culture positive tissue samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep Periprosthetic Joint Infection | 90 days | Number of subjects to have deep periprosthetic joint infection within 90 days of index operation |
Countries
United States
Outcome results
None listed