Necrotizing Soft-tissue InfectionsSURFASTNCT07417982
Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the SURFAST Care Pathway.
An observational study of Necrotizing Soft-tissue Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Necrotizing Soft-tissue Infections
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Jun 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (adults and children) with a suspected or confirmed necrotizing soft-tissue infections (NSTI) managed within the SURFAST care pathway.
Who may be able to join
- 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
Who cannot join
- Patient or legal representative's refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
thomas URBINA, Dr contact
France1 site
Hôpital Henri Mondor, 1 rue Gustave Eiffel,
Créteil, Île-de-France Region, 94000
Nicolas DE PROST, PU-PH, +33 1 45 17 86 37, nicolas.de-prost@aphp.fr
Thomas URBINA, Dr, Tomas.urbina@aphp.fr
About this study
Official title: 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.
- Conditions
- Necrotizing Soft-tissue Infections
- Keywords
- Necrotizing soft-tissue infections, necrotizing fasciitis, Skin and soft tissue necrotizing infections, SURFAST
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| - Adult / limb and abdomino-perineal | Not described | |
| - Adult / cervico-facial | Not described | |
| - Pediatric | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
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
Measured: 90 days
Secondary outcomes (6)
hospital mortality
vital status measured at hospital discharge
Measured: at hospital discharge and within 60 days of hospital admission
time from hospital admission to first surgical debridement
time period measured in hours between first hospital admission and first surgical debridement
Measured: within the first 72 hours of hospital admission
functional outcome and quality of life
measured using the Activity of Daily Living (ADL) and the EQ-5D-5L (EuroQol) French version scores
Measured: day 90 post-admission
amputation rate
toe or limb amputation performed
Measured: day 90
annual case volume per centre
number of NSTI cases managed per year in each centre participating in the SURFAST network
Measured: 123 months
bacteriological documentation
bacterial documentation of NSTIs obtained from blood cultures or cultures of operative tissue samples.
Measured: At the time of blood culture collection or operative tissue sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2036 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft-tissue InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417982
- Sponsor's protocol ID
- APHP251357
- Acronym
- SURFAST
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the Great Paris Area SURFAST Care Pathway: a Prospective, Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT07417982
- Acronym / sponsor ID
- SURFAST / APHP251357
- Conditions
- Necrotizing Soft-tissue Infections
- Keywords
- Necrotizing soft-tissue infections, necrotizing fasciitis, Skin and soft tissue necrotizing infections, SURFAST
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2036 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| - Adult / limb and abdomino-perineal | – | – |
| - Adult / cervico-facial | – | – |
| - Pediatric | – | – |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (adults and children) with a suspected or confirmed necrotizing soft-tissue infections (NSTI) managed within the SURFAST care pathway.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patient or legal representative's refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
hospital mortality
Time frame: 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
functional outcome and quality of life
Time frame: day 90 post-admission
amputation rate
Time frame: day 90
annual case volume per centre
Time frame: 123 months
bacteriological documentation
Time frame: At the time of blood culture collection or operative tissue sampling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
thomas URBINA, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Soft-tissue Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas DE PROST, PU-PH (+33 1 45 17 86 37, nicolas.de-prost@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.