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

Not Applicable

Recruiting

• Conditions: Joint Infection
• Interventions: Other: Saline irrigation; Other: No-Rinse Solution (NS)

• Registration Number: NCT05519007
• Lead Sponsor: Northwell Health

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2023-09-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 936

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Saline irrigation	Saline irrigation
The Next Science treatment	No-Rinse Solution (NS)	The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time

Primary Outcome Measures

Name	Time	Method
infection rate	at 90 days	Joint infection rate after surgery

Secondary Outcome Measures

Name	Time	Method
QT prolongation	up to 24 hours (from the time of irrigation to closure)	Incidences of QT prolongation and short-term hypocalcemia

Trial Locations

Locations (3)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States