Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

NCT ID: NCT02169128

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Necrotizing Fasciitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients and their significant others

Patients affected by necrotizing fasciitis and their significant others

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven-Egron Thörn, MD, ass prof

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Sahlgrenska University hospital

Gothenburg, , Sweden

Site Status RECRUITING

Karolinska Universitetssjukhuset

Solna, , Sweden

Site Status RECRUITING

Countries

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Denmark Sweden

Central Contacts

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Annette Erichsen Andersson, RN, PhD

Role: CONTACT

+46737250458

Ann-Mari Fagerdahl, RN, PhD

Role: CONTACT

+46700891063

Facility Contacts

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Ingrid Egerod, RN, prof

Role: primary

Sven-Egron Thörn, MD, ass prof

Role: primary

+46313434000

Folke Lind, MD, PhD

Role: primary

+46851775557

Other Identifiers

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SSTI

Identifier Type: -

Identifier Source: org_study_id

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