Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
• 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.