Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Necrotizing Fasciitis Clinical Trial

Official title:

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02169128
• Other study ID #: SSTI
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Necrotizing Fasciitis
• Soft Tissue Infections

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