- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417982
Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the SURFAST Care Pathway. (SURFAST)
Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the Great Paris Area SURFAST Care Pathway: a Prospective, Multicenter Cohort Study.
Necrotising soft-tissue infections (NSTIs) are rare and life-threatening skin and soft tissue infections requiring urgent combined medical and surgical management in specialist centres. At Assistance Publique-Hôpitaux de Paris, a multidisciplinary reference network called the SURFAST consortium has been established. This network includes experts in the management of NSTIs, such as intensivists, dermatologists, infectious disease physicians, paediatricians, surgeons, and microbiologists. The consortium manages all NSTI cases referred from the greater Paris area, a large region of France with a population exceeding 12 million.
The SURFAST network comprises care pathways enabling the management of adult and paediatric patients with abdomino-perineal, limb, and cervico-facial NSTIs. All patients managed within this care pathway are included in a prospective, multicentre cohort study. This study examines factors associated with mortality at day 90, long-term sequelae, quality of life, and indicators of the quality of care.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nicolas DE PROST, PU-PH
- Phone Number: +33 1 45 17 86 37
- Email: nicolas.de-prost@aphp.fr
Study Contact Backup
- Name: Thomas URBINA, Dr
- Email: Tomas.urbina@aphp.fr
Study Locations
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Île-de-France Region
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Créteil, Île-de-France Region, France, 94000
- Hôpital Henri Mondor, 1 rue Gustave Eiffel,
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Contact:
- Nicolas DE PROST, PU-PH
- Phone Number: +33 1 45 17 86 37
- Email: nicolas.de-prost@aphp.fr
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Contact:
- Thomas URBINA, Dr
- Email: Tomas.urbina@aphp.fr
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Principal Investigator:
- Nicolas de prost, PH PH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients (adults and children, irrespective of age) managed for suspected or surgically confirmed necrotizing soft-tissue infections (NSTI) • Consent to participate in the study
Exclusion Criteria:
- Patient or legal representative's refusal to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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- Adult / limb and abdomino-perineal
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- Adult / cervico-facial
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- Pediatric
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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mortality
Time Frame: 90 days
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If the patient is still hospitalized, an on-site visit will be conducted; otherwise, the patient or their relative will be contacted by telephone by an investigator or a study coordinator
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital mortality
Time Frame: at hospital discharge and within 60 days of hospital admission
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vital status measured at hospital discharge
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at hospital discharge and within 60 days of hospital admission
|
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time from hospital admission to first surgical debridement
Time Frame: within the first 72 hours of hospital admission
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time period measured in hours between first hospital admission and first surgical debridement
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within the first 72 hours of hospital admission
|
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functional outcome and quality of life
Time Frame: day 90 post-admission
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measured using the Activity of Daily Living (ADL) and the EQ-5D-5L (EuroQol) French version scores
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day 90 post-admission
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amputation rate
Time Frame: day 90
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toe or limb amputation performed
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day 90
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annual case volume per centre
Time Frame: 123 months
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number of NSTI cases managed per year in each centre participating in the SURFAST network
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123 months
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bacteriological documentation
Time Frame: At the time of blood culture collection or operative tissue sampling
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bacterial documentation of NSTIs obtained from blood cultures or cultures of operative tissue samples.
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At the time of blood culture collection or operative tissue sampling
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP251357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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