Last updated: October 12, 2023
Sponsor: Northwell Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Saline irrigation
No-Rinse Solution (NS)
Clinical Study ID
NCT05519007
21-1026
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 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, andD
Study Design
Total Participants: 936
Treatment Group(s): 2
Primary Treatment: Saline irrigation
Phase:
Study Start date:
September 26, 2023
Estimated Completion Date:
March 31, 2025
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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