NCT05519007 · Northwell Health
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
What this study is about
A forward-looking, single-site, double-treatment group$1, parallel, interventional, randomly assigned, 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).
View original scientific description
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).
Interventions
OTHER
No-Rinse Solution (NS)
The surgical site will be irrigated with NS prior to closure,
OTHER
Saline irrigation
The surgical site will be irrigated with Saline
Primary outcome measures
infection rate
Time frame: at 90 days
Joint infection rate after surgery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult that meets at least one of the below criteria at time of screening:
- American Society of Anesthesiologists (ASA) 3 2
- 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 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, and D
Where
- Manhasset, New York
- New Hyde Park, New York
- New York, New York
Collaborators
Next Science TM
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 23, 2025 · Source of record for eligibility and locations