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临床试验/NCT02169128
NCT02169128Unknown不适用

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Göteborg University3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
3
主要终点
Quality of life

研究概览

简要总结

Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients diagnosed with necrotizing fasciitis and their significant others
  • Age above 18 yrs

排除标准

  • Persons with dementia or severe psychiatric illness
  • Persons that do not master the Scandinavian language

结局指标

主要结局

Quality of life

时间窗: 24 months

Quantitative - health related quality of life Qualitative - patient experience

次要结局

  • Quality of life of significant others(24 months)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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