Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

• Conditions: Necrotizing Fasciitis

• Registration Number: NCT02169128
• Lead Sponsor: Göteborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life	24 months	Quantitative - health related quality of life Qualitative - patient experience

Secondary Outcome Measures

Name	Time	Method
Quality of life of significant others	24 months	Quantitative - health related quality of life Qualitative - experience of significant others

Trial Locations

Locations (3)

Sahlgrenska University hospital; 🇸🇪 Gothenburg, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Solna, Sweden

Rigshospitalet; 🇩🇰 Copenhagen, Denmark