跳至主要内容
临床试验/NCT05224817
NCT05224817
Unknown
不适用

Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score

Methodist Health System1 个研究点 分布在 1 个国家目标入组 1,010 人2019年11月1日
适应症Necrosis

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Necrosis
发起方
Methodist Health System
入组人数
1010
试验地点
1
主要终点
mortality length of time in hospital
最后更新
4年前

概览

简要总结

Primary Objective:

The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection.

Secondary Objectives:

To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

详细描述

This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

注册库
clinicaltrials.gov
开始日期
2019年11月1日
结束日期
2023年1月30日
最后更新
4年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI

排除标准

  • Age \<18 years old and age \> 89 years
  • Pregnancy
  • Prisoners
  • Below ankle diabetic foot infections complicated by peripheral vascular disease
  • Burn wounds

结局指标

主要结局

mortality length of time in hospital

时间窗: 30-90 days

Change in the presence of necrosis

时间窗: up to 30 days

thrombosed vessels or absence of bleeding

研究点 (1)

Loading locations...

相似试验