RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-09-26
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05519007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult that meets at least one of the below criteria at time of screening:
  2. * American Society of Anesthesiologists (ASA) 3 2
  3. * BMI \>35
  4. * Patient with functional limitations as a result of disease1:
  5. * Poorly treated hypertension
  6. * Poorly treated diabetes
  7. * Chronic renal failure
  8. * Bronchospastic disease
  9. * Disease with intermittent exacerbations
  10. * Stable angina
  11. * Implanted pacemaker
  12. * Known history as an active nicotine use (smoker)
  13. * Known history of uncontrolled diabetes mellitus (HgbA1C \> 7.0)
  14. * Known history of end stage organ disease
  15. * Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
  16. * Known history of current active cancer treatment (chemotherapy)
  17. * Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
  18. * Charleston Comorbidity Score \> 2
  19. * Elixhauser Score \>11
  20. * Age 65 or older
  21. 2. Subject is scheduled to primary joint replacement.
  22. 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.
  23. 4. Subject has understood, signed, and dated the informed consent form.
  1. 1. Unable to provide signed and dated informed consent.
  2. 2. Unable or unwilling to comply with all study-related procedures.
  3. 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. 4. Subject has contraindications to general anesthesia
  5. 5. Any subject positive for Covid-19 virus at time of surgical screening
  6. 6. Subjects have evidence of prolonged QT segment, per EKG.
  7. 7. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D

Contacts and Locations

Study Contact

Meriton Ruhani
CONTACT
(212)434-4724
ruhanimeriton@gmail.com

Principal Investigator

Giles Scuderi
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

North Shore University Hospital
Manhasset, New York, 11030
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Lenox Hill Hospital
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Giles Scuderi, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-26
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-09-26
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Joint Infection