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Not yet recruiting NCT07417982

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

Observational Necrotizing Soft-tissue Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Necrotizing Soft-tissue Infections. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • mortality [Time frame: 90 days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Henri Mondor, 1 rue Gustave Eiffel, — Créteil

Identifiers

NCT: NCT07417982 · APHP251357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗