Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
1 other identifier
observational
30
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 14, 2018
August 1, 2018
4.9 years
June 19, 2014
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Quality of life
Quantitative - health related quality of life Qualitative - patient experience
6 months
Quality of life
Quantitative - health related quality of life Qualitative - patient experience
24 months
Secondary Outcomes (2)
Quality of life of significant others
6 months
Quality of life of significant others
24 months
Study Arms (1)
Patients and their significant others
Patients affected by necrotizing fasciitis and their significant others
Eligibility Criteria
Patients treated for necrotizing fasciitis at the three study sites
You may qualify if:
- Patients diagnosed with necrotizing fasciitis and their significant others
- Age above 18 yrs
You may not qualify if:
- Persons with dementia or severe psychiatric illness
- Persons that do not master the Scandinavian language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Sahlgrenska University Hospitalcollaborator
- Karolinska Institutetcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (3)
Rigshospitalet
Copenhagen, 4131, Denmark
Sahlgrenska University hospital
Gothenburg, 416 85, Sweden
Karolinska Universitetssjukhuset
Solna, 171 64, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sven-Egron Thörn, MD, ass prof
Sahlgrenska University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2014
First Posted
June 23, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
August 14, 2018
Record last verified: 2018-08