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Clinical Trials/NCT02169128
NCT02169128
Unknown
Not Applicable

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Göteborg University3 sites in 2 countries30 target enrollmentStarted: January 2014Last updated:

Overview

Phase
Not Applicable
Sponsor
Göteborg University
Enrollment
30
Locations
3
Primary Endpoint
Quality of life

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Quality of life

Time Frame: 24 months

Quantitative - health related quality of life Qualitative - patient experience

Secondary Outcomes

  • Quality of life of significant others(24 months)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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