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Status unknownNCT02169128Updated Aug 14, 2018

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

An observational study in Necrotizing Fasciitis, sponsored by Göteborg University. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Göteborg University · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Necrotizing Fasciitis

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03

In context

Fasciitis, Necrotizing

28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.

This study's planned enrollment of 30 is below the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.

Browse Fasciitis, Necrotizing studies →

Lead sponsor

Göteborg University is the lead sponsor of 270 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated for necrotizing fasciitis at the three study sites

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with necrotizing fasciitis and their significant others
  • Age above 18 yrs

Exclusion criteria

Exclusion Criteria:

  • Persons with dementia or severe psychiatric illness
  • Persons that do not master the Scandinavian language
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients and their significant others

    Patients affected by necrotizing fasciitis and their significant others

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What researchers measure

Primary outcomes

  1. Quality of life

    Quantitative - health related quality of life Qualitative - patient experience

    Time frame: 6 months

  2. Quality of life

    Quantitative - health related quality of life Qualitative - patient experience

    Time frame: 24 months

Secondary outcomes

  1. Quality of life of significant others

    Quantitative - health related quality of life Qualitative - experience of significant others

    Time frame: 6 months

  2. Quality of life of significant others

    Quantitative - health related quality of life Qualitative - experience of significant others

    Time frame: 24 months

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Study locations

3 of 3 sites recruiting
  • Rigshospitalet
    Copenhagen, 4131, Denmark
    Recruiting
  • Sahlgrenska University hospital
    Gothenburg, 416 85, Sweden
    Recruiting
    • Sven-Egron Thörn, MD, ass prof · Contactsven-egron.thorn@vgregion.se · +46313434000
    • Annette Erichsen Andersson, RN, PhD · Principal investigator
  • Karolinska Universitetssjukhuset
    Solna, 171 64, Sweden
    Recruiting
    • Folke Lind, MD, PhD · Contactfolke.lind@karolinska.se · +46851775557
    • Ann-Mari Fagerdahl, RN, PhD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02169128
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Jan 2014
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 14, 2018

Study contacts

Annette Erichsen Andersson, RN, PhD
Contact
annette.erichsen.andersson@gu.se
+46737250458
Ann-Mari Fagerdahl, RN, PhD
Contact
ann-mari.fagerdahl@ki.se
+46700891063
Sven-Egron Thörn, MD, ass prof
study director · Sahlgrenska University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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