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

Recruiting now · Not applicable

Conditions studied: Joint Infection

In brief

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

Key facts

Study ID

NCT05519007

Run by

Northwell Health

People needed

936

Starts

2023-09-26

Expected to finish

2026-12-31

Last updated by the study team

2025-05-23

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• North Shore University Hospital — Manhasset, New York, United States (enrolling)
• Long Island Jewish Medical Center — New Hyde Park, New York, United States (enrolling)
• Lenox Hill Hospital — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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