Phase
Condition
N/ATreatment
No-Rinse Solution (NS)
Saline irrigation
Clinical Study ID
All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 rheumatologicalmedication (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 includingtransportation to the study site for all scheduled visits and be available for theduration of the study.
Subject has understood, signed, and dated the informed consent form.
Exclusion
Exclusion Criteria:
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 anycoverings)
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
Study Design
Connect with a study center
North Shore University Hospital
Manhasset, New York 11030
United StatesActive - Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesActive - Recruiting
Lenox Hill Hospital
New York, New York 10075
United StatesActive - Recruiting

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