Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05519007 | RECRUITING | Joint Infection

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

Northwell Health

Information provided by (Responsible Party):

Giles Scuderi

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

Condition or disease

Joint Infection

Intervention/treatment

No-Rinse Solution (NS)

Saline irrigation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 936 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Actual Study Start Date : 2023-09-26
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

Location Details

NCT05519007

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

North Shore University Hospital

Manhasset, New York, United States, 11030

RECRUITING

United States, New York

Long Island Jewish Medical Center

New Hyde Park, New York, United States, 11040

RECRUITING

United States, New York

Lenox Hill Hospital

New York, New York, United States, 10075