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

May 20, 2025 updated by: Giles Scuderi, Northwell Health

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

936

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
          • Meriton Ruhani
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Long Island Jewish Medical Center
        • Contact:
          • Meriton Ruhani
      • New York, New York, United States, 10075

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Next Science treatment
The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time
Other: No-Rinse Solution (NS)
The surgical site will be irrigated with NS prior to closure,
Active Comparator: Standard of Care
Saline irrigation
Other: Saline irrigation
The surgical site will be irrigated with Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection rate
Time Frame: at 90 days
Joint infection rate after surgery
at 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT prolongation
Time Frame: up to 24 hours (from the time of irrigation to closure)
Incidences of QT prolongation and short-term hypocalcemia
up to 24 hours (from the time of irrigation to closure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

Next Science TM

Investigators

  • Principal Investigator: Giles Scuderi, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Joint Infection

Clinical Trials on No-Rinse Solution (NS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe