Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the SURFAST Care Pathway. (SURFAST)

February 10, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94000
        • Hôpital Henri Mondor, 1 rue Gustave Eiffel,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas de prost, PH PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients (adults and children) with a suspected or confirmed necrotizing soft-tissue infections (NSTI) managed within the SURFAST care pathway.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
- Adult / limb and abdomino-perineal
- Adult / cervico-facial
- Pediatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 90 days
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital mortality
Time Frame: at hospital discharge and within 60 days of hospital admission
vital status measured at hospital discharge
at hospital discharge and within 60 days of hospital admission
time from hospital admission to first surgical debridement
Time Frame: within the first 72 hours of hospital admission
time period measured in hours between first hospital admission and first surgical debridement
within the first 72 hours of hospital admission
functional outcome and quality of life
Time Frame: day 90 post-admission
measured using the Activity of Daily Living (ADL) and the EQ-5D-5L (EuroQol) French version scores
day 90 post-admission
amputation rate
Time Frame: day 90
toe or limb amputation performed
day 90
annual case volume per centre
Time Frame: 123 months
number of NSTI cases managed per year in each centre participating in the SURFAST network
123 months
bacteriological documentation
Time Frame: At the time of blood culture collection or operative tissue sampling
bacterial documentation of NSTIs obtained from blood cultures or cultures of operative tissue samples.
At the time of blood culture collection or operative tissue sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2036

Study Completion (Estimated)

June 1, 2036

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Necrotizing Soft-tissue Infections

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