NCT05519007 Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
| NCT ID | NCT05519007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 936 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 936 participants in total. It began in 2023-09-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Giles Scuderi
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT05519007 clinical trial?
This trial is open to participants of all sexes, studying Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05519007 currently recruiting?
Yes, NCT05519007 is actively recruiting participants. Contact the research team at ruhanimeriton@gmail.com for enrollment information.
Where is the NCT05519007 trial being conducted?
This trial is being conducted at Manhasset, United States, New Hyde Park, United States, New York, United States.
Who is sponsoring the NCT05519007 clinical trial?
NCT05519007 is sponsored by Northwell Health. The principal investigator is Giles Scuderi at Northwell Health. The trial plans to enroll 936 participants.