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Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

NCT02169128 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-08-14

No results posted yet for this study

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.

Conditions

  • Necrotizing Fasciitis

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Sven-Egron Thörn, MD, ass prof · Sahlgrenska University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Denmark
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169128 on ClinicalTrials.gov