Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

Inclusion criteria

• Adult that meets at least one of the below criteria at time of screening:

• American Society of Anesthesiologists (ASA) 3 2
• BMI >35
• Patient with functional limitations as a result of disease1:

• Poorly treated hypertension
• Poorly treated diabetes
• Chronic renal failure
• Bronchospastic disease
• Disease with intermittent exacerbations
• Stable angina
• Implanted pacemaker
• Known history as an active nicotine use (smoker)
• Known history of uncontrolled diabetes mellitus (HgbA1C > 7.0)
• Known history of end stage organ disease
• Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
• Known history of current active cancer treatment (chemotherapy)
• Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
• Charleston Comorbidity Score > 2
• Elixhauser Score >11
• Age 65 or older
• Subject is scheduled to primary joint replacement.
• Subject is willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study.
• Subject has understood, signed, and dated the informed consent form.

Exclusion criteria

• Unable to provide signed and dated informed consent.
• Unable or unwilling to comply with all study-related procedures.
• Known history of 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)
• Subject has contraindications to general anesthesia
• Any subject positive for Covid-19 virus at time of surgical screening
• Subjects have evidence of prolonged QT segment, per EKG.
• Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D