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

Northwell Health

Status: Enrolling

Conditions: Joint Infection

Treatments: Other: Saline irrigation; Other: No-Rinse Solution (NS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05519007

21-1026

Details and patient eligibility

About

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

Enrollment: 936 estimated patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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936 participants in 2 patient groups

The Next Science treatment

Experimental group

Description:

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

Treatment:

Other: No-Rinse Solution (NS)

Standard of Care

Active Comparator group

Description:

Saline irrigation

Treatment:

Other: Saline irrigation