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Recruiting NCT05519007

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

No phase Interventional Joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No-Rinse Solution (NS), Saline irrigation.
Who it may be relevant to
Registry conditions: Joint Infection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

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

Primary outcome measures

  • infection rate [Time frame: at 90 days]
Secondary outcome measures (1)
  • QT prolongation [Time frame: up to 24 hours (from the time of irrigation to closure)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • North Shore University Hospital — Manhasset
  • Long Island Jewish Medical Center — New Hyde Park
  • Lenox Hill Hospital — New York

Publications

  • 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. PMID 31020036
  • 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/
  • 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. PMID 24195875
  • 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. PMID 24055383

Identifiers

NCT: NCT05519007 · 21-1026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗