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Trial record 4 of 16 for:    Necrotizing Fascitis

Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

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ClinicalTrials.gov Identifier: NCT02169128
Recruitment Status : Recruiting
First Posted : June 23, 2014
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Karolinska Institutet
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease
Necrotizing Fasciitis

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
    Quantitative - health related quality of life Qualitative - patient experience

  2. Quality of life [ Time Frame: 24 months ]
    Quantitative - health related quality of life Qualitative - patient experience


Secondary Outcome Measures :
  1. Quality of life of significant others [ Time Frame: 6 months ]
    Quantitative - health related quality of life Qualitative - experience of significant others

  2. Quality of life of significant others [ Time Frame: 24 months ]
    Quantitative - health related quality of life Qualitative - experience of significant others



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for necrotizing fasciitis at the three study sites
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169128


Contacts
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Contact: Annette Erichsen Andersson, RN, PhD +46737250458 annette.erichsen.andersson@gu.se
Contact: Ann-Mari Fagerdahl, RN, PhD +46700891063 ann-mari.fagerdahl@ki.se

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

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02169128     History of Changes
Other Study ID Numbers: SSTI
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Soft Tissue Infections
Fasciitis, Necrotizing
Fasciitis
Infection
Musculoskeletal Diseases
Skin Diseases, Bacterial
Bacterial Infections