Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
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
936 participants
Sep 26, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria23
- 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.
Exclusion Criteria7
- 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
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Interventions
The surgical site will be irrigated with NS prior to closure,
The surgical site will be irrigated with Saline
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05519007