Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Northwell Health
Summary
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
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. 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 en…
Interventions
- OtherNo-Rinse Solution (NS)
The surgical site will be irrigated with NS prior to closure,
- OtherSaline irrigation
The surgical site will be irrigated with Saline
Locations (3)
- North Shore University HospitalManhasset, New York
- Long Island Jewish Medical CenterNew Hyde Park, New York
- Lenox Hill HospitalNew York, New York