Clinical trial NCT05519007: 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
Overall status: RECRUITING
Phase: NA
Conditions: Joint Infection
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Next Science TM
First posted: 2022-08-29
Enrollment: 936
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: infection rate
timeFrame: at 90 days
Secondary outcomes:
measure: QT prolongation
timeFrame: up to 24 hours (from the time of irrigation to closure)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Giles Scuderi
role: PRINCIPAL_INVESTIGATOR
References:
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.
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/
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.
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.