Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02169128

Enrollment

Registered

2014-06-23

Start date

2014-01-31

Completion date

2019-12-31

Last updated

2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Fasciitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of life	6 months	Quantitative - health related quality of life Qualitative - patient experience

Secondary

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

Countries

Denmark, Sweden

Contacts

Primary ContactAnnette Erichsen Andersson, RN, PhD

annette.erichsen.andersson@gu.se+46737250458

Backup ContactAnn-Mari Fagerdahl, RN, PhD

ann-mari.fagerdahl@ki.se+46700891063

Outcome results