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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
936
The surgical site will be irrigated with NS prior to closure,
The surgical site will be irrigated with Saline
North Shore University Hospital
Manhasset, New York, United States
RECRUITINGLong Island Jewish Medical Center
New Hyde Park, New York, United States
RECRUITINGLenox Hill Hospital
New York, New York, United States
RECRUITINGinfection rate
Joint infection rate after surgery
Time frame: at 90 days
QT prolongation
Incidences of QT prolongation and short-term hypocalcemia
Time frame: up to 24 hours (from the time of irrigation to closure)
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