MedTrace Logo

SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

NCT05116956 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1033

Last updated 2021-11-23

No results posted yet for this study

Summary

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not.

The objectives of the study are :

1. To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes
2. To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

Conditions

  • Necrotizing Fasciitis
  • Fournier Gangrene
  • Necrotizing Soft Tissue Infection

Interventions

OTHER

non interventional

Multinational prospective, standard care data collection, non-interventional, study not involving human subjects

Sponsors & Collaborators

  • European Society of Intensive Care Medicine

    collaborator OTHER

  • Henri Mondor University Hospital

    lead OTHER

Principal Investigators

  • Nicolas de Prost, MD, PhD · Service MIR, Hôpital Henri Mondor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2023-07-22
Completion
2023-07-22

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116956 on ClinicalTrials.gov