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临床试验/NCT07417982
NCT07417982尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
mortality

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

- Adult / limb and abdomino-perineal

- Adult / cervico-facial

- Pediatric

结局指标

主要结局

mortality

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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