Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

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.

Study Overview

• Status: Unknown
• Conditions: Necrotizing Fasciitis

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 4131
    • Recruiting
    • Rigshospitalet
    • Contact: Ingrid Egerod, RN, prof; Email: ingrid.egerod@regionh.dk
    • Principal Investigator: Martin Bruun Madsen, MD
• Sweden
  • Gothenburg, Sweden, 416 85
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Sven-Egron Thörn, MD, ass prof; Phone Number: +46313434000; Email: sven-egron.thorn@vgregion.se
    • Principal Investigator: Annette Erichsen Andersson, RN, PhD
  • Solna, Sweden, 171 64
    • Recruiting
    • Karolinska Universitetssjukhuset
    • Contact: Folke Lind, MD, PhD; Phone Number: +46851775557; Email: folke.lind@karolinska.se
    • Principal Investigator: Ann-Mari Fagerdahl, RN, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for necrotizing fasciitis at the three study sites

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients and their significant others; Patients affected by necrotizing fasciitis and their significant others

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of significant others	Quantitative - health related quality of life Qualitative - experience of significant others	6 months
Quality of life of significant others	Quantitative - health related quality of life Qualitative - experience of significant others	24 months

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Karolinska Institutet; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden
• Investigators: Study Director: Sven-Egron Thörn, MD, ass prof, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Soft Tissue Infections; Fasciitis; Fasciitis, Necrotizing
• Other Study ID Numbers: SSTI