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

Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519007
• Other study ID #: 21-1026
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: Meriton Ruhani
• Phone: (212)434-4724
• Email: ruhanimeriton[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 936
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Joint Infection

Intervention

Other:
• No-Rinse Solution (NS)
The surgical site will be irrigated with NS prior to closure,
• Saline irrigation
The surgical site will be irrigated with Saline

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Next Science TM

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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/

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection rate	Joint infection rate after surgery	at 90 days
Secondary	QT prolongation	Incidences of QT prolongation and short-term hypocalcemia	up to 24 hours (from the time of irrigation to closure)