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

Primary Purpose

Joint Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No-Rinse Solution (NS)
Saline irrigation
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North Shore University HospitalRecruiting
  • Long Island Jewish Medical CenterRecruiting
  • Lenox Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The Next Science treatment

Standard of Care

Arm Description

The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time

Saline irrigation

Outcomes

Primary Outcome Measures

infection rate
Joint infection rate after surgery

Secondary Outcome Measures

QT prolongation
Incidences of QT prolongation and short-term hypocalcemia

Full Information

First Posted
August 25, 2022
Last Updated
October 12, 2023
Sponsor
Northwell Health
Collaborators
Next Science TM
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1. Study Identification

Unique Protocol Identification Number
NCT05519007
Brief Title
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Next Science TM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
936 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Next Science treatment
Arm Type
Experimental
Arm Description
The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Saline irrigation
Intervention Type
Other
Intervention Name(s)
No-Rinse Solution (NS)
Intervention Description
The surgical site will be irrigated with NS prior to closure,
Intervention Type
Other
Intervention Name(s)
Saline irrigation
Intervention Description
The surgical site will be irrigated with Saline
Primary Outcome Measure Information:
Title
infection rate
Description
Joint infection rate after surgery
Time Frame
at 90 days
Secondary Outcome Measure Information:
Title
QT prolongation
Description
Incidences of QT prolongation and short-term hypocalcemia
Time Frame
up to 24 hours (from the time of irrigation to closure)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Subject is scheduled to primary joint replacement. 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. Subject has understood, signed, and dated the informed consent form. Exclusion Criteria: Unable to provide signed and dated informed consent. Unable or unwilling to comply with all study-related procedures. 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) Subject has contraindications to general anesthesia Any subject positive for Covid-19 virus at time of surgical screening Subjects have evidence of prolonged QT segment, per EKG. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meriton Ruhani
Phone
(212)434-4724
Email
ruhanimeriton@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giles Scuderi
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meriton Ruhani
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meriton Ruhani
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meriton Ruhani
Email
mruhani@northwell.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31020036
Citation
Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
Results Reference
background
Citation
Doyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
Results Reference
background
PubMed Identifier
24195875
Citation
Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
Results Reference
background
PubMed Identifier
24055383
Citation
Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
Results Reference
background

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

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