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临床试验/NCT07170020
NCT07170020尚未招募不适用

Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

Spectrum Health Hospitals1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
试验地点
1
主要终点
Mortality improvement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Pediatric patients
  • •Pregnant patients
  • •Patients deemed unlikely to survive or unable to go to surgical debridement

研究组 & 干预措施

determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments

Experimental

Secondary objectives will be to evaluate the morbidity of patients treated with standard of care including hyperbaric oxygen treatments as compared to historical controls. Morbidity metrics include: decreased need for OR debridement, improved quality of life (QOL) scores, reduced mortality, reduced complications, reduced hospital length of stay.

干预措施: Hyperbaric Oxygen Therapy (Procedure)

Will the hyperbaric oxygen improve morbidity and mortality compared to standard of care

Experimental

We hypothesize the addition of hyperbaric oxygen in conjunction with standard care will improve patient mortality in necrotizing soft tissue infections. This study will evaluate if the addition ofhyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.

干预措施: Hyperbaric Oxygen Therapy (Procedure)

结局指标

主要结局

Mortality improvement

时间窗: 6 months post procedure

To evaluate if the addition of hyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.

次要结局

  • Morbitity(6 months post procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Drue Orwig

Section Chief, Hyperbaric/Wound Care

Spectrum Health Hospitals

研究点 (1)

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