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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02169128
Other study ID # SSTI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date December 2019

Study information

Verified date August 2018
Source Göteborg University
Contact Annette Erichsen Andersson, RN, PhD
Phone +46737250458
Email annette.erichsen.andersson@gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen
Sweden Sahlgrenska University hospital Gothenburg
Sweden Karolinska Universitetssjukhuset Solna

Sponsors (4)

Lead Sponsor Collaborator
Göteborg University Karolinska Institutet, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life Quantitative - health related quality of life Qualitative - patient experience 6 months
Primary Quality of life Quantitative - health related quality of life Qualitative - patient experience 24 months
Secondary Quality of life of significant others Quantitative - health related quality of life Qualitative - experience of significant others 6 months
Secondary Quality of life of significant others Quantitative - health related quality of life Qualitative - experience of significant others 24 months
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