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Clinical Trials/NCT07417982
NCT07417982
Not yet recruiting
Not Applicable

Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the Great Paris Area SURFAST Care Pathway: a Prospective, Multicenter Cohort Study.

Assistance Publique - Hôpitaux de Paris1 site in 1 country1,000 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
mortality

Overview

Brief 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. 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

- Adult / limb and abdomino-perineal

- Adult / cervico-facial

- Pediatric

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • functional outcome and quality of life(day 90 post-admission)
  • amputation rate(day 90)
  • annual case volume per centre(123 months)
  • hospital mortality(at hospital discharge and within 60 days of hospital admission)
  • time from hospital admission to first surgical debridement(within the first 72 hours of hospital admission)
  • bacteriological documentation(At the time of blood culture collection or operative tissue sampling)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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