Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

Study Purpose

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.#46;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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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.

2. Subject is scheduled to primary joint replacement. 3. 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. 4. Subject has understood, signed, and dated the informed consent form.

Exclusion Criteria:

1. Unable to provide signed and dated informed consent. 2. Unable or unwilling to comply with all study-related procedures. 3. 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) 4. Subject has contraindications to general anesthesia. 5. Any subject positive for Covid-19 virus at time of surgical screening. 6. Subjects have evidence of prolonged QT segment, per EKG. 7. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05519007
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwell Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Giles Scuderi
Principal Investigator Affiliation	Northwell Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Joint Infection

Arms & Interventions

Arms

Experimental: The Next Science treatment

The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time

Active Comparator: Standard of Care

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

North Shore University Hospital, Manhasset, New York

Status

Recruiting

Address

North Shore University Hospital

Manhasset, New York, 11030

Site Contact

Meriton Ruhani

[email protected]

(212)434-4724

Long Island Jewish Medical Center, New Hyde Park, New York

Status