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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient or legal representative's refusal to participate in the study

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups
Group A: - Adult / limb and abdomino-perineal
Group B: - Adult / cervico-facial
Group C: - Pediatric

Trial outcomes

Primary outcomes

1

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

Time frame
90 days

Secondary outcomes

1

hospital mortality

vital status measured at hospital discharge

Time frame
at hospital discharge and within 60 days of hospital admission
2

time from hospital admission to first surgical debridement

time period measured in hours between first hospital admission and first surgical debridement

Time frame
within the first 72 hours of hospital admission
3

functional outcome and quality of life

measured using the Activity of Daily Living (ADL) and the EQ-5D-5L (EuroQol) French version scores

Time frame
day 90 post-admission
4

amputation rate

toe or limb amputation performed

Time frame
day 90

Other outcomes

Sponsors and contacts

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