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
American Society of Anesthesiologists (ASA) 3 2
BMI >35
Poorly treated hypertension
Poorly treated diabetes
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
Parallel
No-Rinse Solution (NS)
Other interventionThe surgical site will be irrigated with NS prior to closure,
Saline irrigation
Other interventionThe surgical site will be irrigated with Saline
infection rate
Joint infection rate after surgery
QT prolongation
Incidences of QT prolongation and short-term hypocalcemia
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Northwell Health
Lead sponsor
Next Science TM
Collaborator
