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

RecruitingHealthy volunteers welcome

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

Who can join

All ages · All sexes · Healthy volunteers welcome

Full 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

About the study

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

What is being tested

Sponsor: Northwell Health · Participants: 936 · Started: Sep 26, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05519007

Locations in the U.S.

New YorkNorth Shore University Hospital, Manhasset
Long Island Jewish Medical Center, New Hyde Park
Lenox Hill Hospital, New York

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.