NCT05116956 (SKIN-ICU) is a clinical trial of non interventional in Necrotizing Fasciitis, sponsored by Henri Mondor University Hospital.

Who is sponsoring NCT05116956?

NCT05116956 is sponsored by Henri Mondor University Hospital.

What drugs are being tested in NCT05116956?

Interventions in NCT05116956: non interventional.

What condition does NCT05116956 study?

NCT05116956 studies Necrotizing Fasciitis, Fournier Gangrene, Necrotizing Soft Tissue Infection.

Is NCT05116956 still recruiting?

NCT05116956 is currently status unknown. Last updated 23 November 2021.

Last reviewed 2021-11-23 · How we verify

NCT05116956: SKIN-ICU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Last updated 23 November 2021

What this trial tests

trial testing non interventional in Necrotizing Fasciitis in 1,033 participants. Status unknown.

Timeline

8 November 2021

Primary endpoint
22 July 2023

22 July 2023

Quick facts

Lead sponsor	Henri Mondor University Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,033
Start date	8 November 2021
Primary completion	22 July 2023
Estimated completion	22 July 2023
Sites	1 location across France

Drugs / interventions tested

non interventional

Conditions studied

Necrotizing Fasciitis — all drugs for Necrotizing Fasciitis →
Fournier Gangrene — all drugs for Fournier Gangrene →
Necrotizing Soft Tissue Infection — all drugs for Necrotizing Soft Tissue Infection →

Sponsor

Henri Mondor University Hospital

Who can join

18 and older, any sex, with Necrotizing Fasciitis or Fournier Gangrene. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

ESICM LIVES 2025
· 2025

Verify or expand the search:

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Currently open trials in the same condition.

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Other Henri Mondor University Hospital trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05116956 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Henri Mondor University Hospital
Last refreshed: 23 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05116956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing