Actively Recruiting
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Led by Northwell Health · Updated on 2025-05-23
936
Participants Needed
3
Research Sites
170 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
Next Science TM
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult scheduled for primary joint replacement surgery
- Meets at least one risk criteria such as ASA score 3 or 2, BMI over 35, or functional limitations due to diseases like poorly treated hypertension or diabetes
- History of active nicotine use (smoker)
- History of uncontrolled diabetes mellitus with HgbA1C over 7.0
- History of end stage organ disease
- History of inflammatory arthritis currently treated with rheumatological medication (DMARDs)
- History of active cancer treatment (chemotherapy)
- Venous disease as per surgical risk calculator
- Charleston Comorbidity Score greater than 2
- Elixhauser Score greater than 11
- Age 65 or older
- Willing and able to comply with study procedures and visits
- Signed and dated informed consent form
You will not qualify if you...
- Unable to provide signed and dated informed consent
- Unable or unwilling to comply with study procedures
- Known allergy to study products or components including standard of care dressings or coverings
- Contraindications to general anesthesia
- Positive for Covid-19 virus at surgical screening
- Evidence of prolonged QT segment on EKG
- Member of a vulnerable population as defined by 45 CFR 46 Subparts B, C, and D
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
3
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
Research Team
M
Meriton Ruhani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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