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Идёт набор NCT05519007

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

Без фазы С лечением Joint Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No-Rinse Solution (NS), Saline irrigation.
Кому может быть актуально
Состояния в реестре: Joint Infection. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

  • infection rate [Срок оценки: at 90 days]
Вторичные конечные точки (1)
  • QT prolongation [Срок оценки: up to 24 hours (from the time of irrigation to closure)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT05519007 · 21-1026

Первоисточники (государственные реестры)

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