Набор скоро начнётся NCT07170020

Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

Без фазы С лечением Necrotizing Fascitis

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: Hyperbaric Oxygen Therapy.
Кому может быть актуально: Состояния в реестре: Necrotizing Fascitis. Базовые параметры: от 18 лет · 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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Обзор

The goal of this clinical trial is to learn if hyperbaric oxygen is beneficial in treating necrotizing infections and decreasing rates of morbidity and mortality. This study therefore has two aims: 1. Determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model. 2. Determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.

Подробное описание

Necrotizing fasciitis and necrotizing soft tissue infections are a complicated group of infections dominated largely by polymicrobial infections that rapidly spread through the skin and soft tissues. Secondary effects include vascular occlusion, ischemia, tissue necrosis, along with sepsis and multi-organ involvement. The incidence of necrotizing infections is about 6500 cases annually in the US2. There have been no major advances in disease management over the past twenty years and the mortality still ranges in the 10-43 % range2. Today early aggressive debridement and IV antibiotics remain the cornerstone of treatment. Hyperbaric oxygen has been shown in several case studies and retrospective studies to possibly improve mortality and morbidity in this patient population.1-4 One limitation of prior studies is many of them are retrospective. Additionally, not all centers are able to take patients quickly back for surgical debridement which could increase rates of morbidity and mortality. Corewell Health West Butterworth Hospital has 24/7 in-hospital acute care surgery services. This allows very short diagnosis to OR debridement wait times in necrotizing infections. This study therefore has two aims: first is to determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model. Secondly, to determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.

Вмешательства

Процедура Hyperbaric Oxygen Therapy
Hyperbaric oxygen has been shown in several case studies and retrospective studies to possibly improve mortality and morbidity in this patient population. One limitation of prior studies is many of them are retrospective. This study will be prospective.

Первичные конечные точки

Mortality improvement [Срок оценки: 6 months post procedure]

Вторичные конечные точки (1)

Morbitity [Срок оценки: 6 months post procedure]

Критерии участия

Критерии включения

Age: 18 years old
Patients with documented necrotizing fasciitis or necrotizing soft tissue infection as assessed during initial bedside evaluation, in conjunction with available laboratory values, imaging showing gas in soft tissues consitent with necrotizing infection, or surgical debridement of necrosis of fascia, muscle, and variable levels of soft tissue involvement
Patient or advocate is able to sign consent