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Trial record 4 of 17 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

Tracking Information
First Submitted Date June 19, 2014
First Posted Date June 23, 2014
Last Update Posted Date August 14, 2018
Study Start Date January 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2014)
  • Quality of life [ Time Frame: 6 months ]
    Quantitative - health related quality of life Qualitative - patient experience
  • Quality of life [ Time Frame: 24 months ]
    Quantitative - health related quality of life Qualitative - patient experience
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02169128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 20, 2014)
  • Quality of life of significant others [ Time Frame: 6 months ]
    Quantitative - health related quality of life Qualitative - experience of significant others
  • Quality of life of significant others [ Time Frame: 24 months ]
    Quantitative - health related quality of life Qualitative - experience of significant others
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
Official Title Severe Soft Tissue Infections: Perspectives of Patients and Significant Others
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated for necrotizing fasciitis at the three study sites
Condition Necrotizing Fasciitis
Intervention Not Provided
Study Groups/Cohorts Patients and their significant others
Patients affected by necrotizing fasciitis and their significant others
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 20, 2014)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Annette Erichsen Andersson, RN, PhD +46737250458 annette.erichsen.andersson@gu.se
Contact: Ann-Mari Fagerdahl, RN, PhD +46700891063 ann-mari.fagerdahl@ki.se
Listed Location Countries Denmark,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02169128
Other Study ID Numbers SSTI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Göteborg University
Study Sponsor Göteborg University
Collaborators
  • Sahlgrenska University Hospital, Sweden
  • Karolinska Institutet
  • Rigshospitalet, Denmark
Investigators
Study Director: Sven-Egron Thörn, MD, ass prof Sahlgrenska University Hospital, Sweden
PRS Account Göteborg University
Verification Date August 2018