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

Last updated: October 12, 2023
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Saline irrigation

No-Rinse Solution (NS)

Clinical Study ID

NCT05519007
21-1026
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 rheumatologicalmedication (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
  1. Subject is scheduled to primary joint replacement.
  2. Subject is willing and able to comply with all study procedures includingtransportation to the study site for all scheduled visits and be available for theduration of the study.
  3. Subject has understood, signed, and dated the informed consent form.

Exclusion

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, andD

Study Design

Total Participants: 936
Treatment Group(s): 2
Primary Treatment: Saline irrigation
Phase:
Study Start date:
September 26, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

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