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

NCT05116956 | Unknown DMC

• 1 other identifier: 1-0_30042021
• Study Type: observational
• Target: 1,033
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

necrotizing soft tissue infection; Necrotizing Fasciitis; Fournier Gangrene

Outcome Measures

Primary Outcomes (1)

• mortality

  day 90

Secondary Outcomes (9)

• Functional outcome

  day 90

• Health-related quality of life outcome

  day 90

• Microbiology

  During the first 72 hours of hospital admission

• Skin grafting and amputation

  At day 90

• SAPS II score

  Within 24 hours of hospital admission

Interventions

non interventional OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with surgically-confirmed NSTI

You may qualify if:

• Age \> 18 years
• Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis)

You may not qualify if:

• Patient deprived of liberty by judicial or administrative decision or patient under guardianship
• Expressed opposition to project's participation at the project

Sponsors & Collaborators

• Henri Mondor University Hospital: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (1)

Hopital Henri Mondor

Créteil, 94000, France

RECRUITING

Related Publications (5)

• Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. No abstract available.

  PMID: 29211672 BACKGROUND

• Urbina T, Canoui-Poitrine F, Hua C, Layese R, Alves A, Ouedraogo R, Bosc R, Sbidian E, Chosidow O, Dessap AM, de Prost N; Henri Mondor Hospital Necrotizing Fasciitis Group. Long-term quality of life in necrotizing soft-tissue infection survivors: a monocentric prospective cohort study. Ann Intensive Care. 2021 Jul 2;11(1):102. doi: 10.1186/s13613-021-00891-9.

  PMID: 34213694 BACKGROUND

• Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014 Jul 15;59(2):147-59. doi: 10.1093/cid/ciu296. Epub 2014 Jun 18.

  PMID: 24947530 BACKGROUND

• Peetermans M, de Prost N, Eckmann C, Norrby-Teglund A, Skrede S, De Waele JJ. Necrotizing skin and soft-tissue infections in the intensive care unit. Clin Microbiol Infect. 2020 Jan;26(1):8-17. doi: 10.1016/j.cmi.2019.06.031. Epub 2019 Jul 5.

  PMID: 31284035 BACKGROUND

• Madsen MB, Skrede S, Bruun T, Arnell P, Rosen A, Nekludov M, Karlsson Y, Bergey F, Saccenti E, Martins Dos Santos VAP, Perner A, Norrby-Teglund A, Hyldegaard O. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT): protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2018 Feb;62(2):272-279. doi: 10.1111/aas.13024. Epub 2017 Oct 29.

  PMID: 29082520 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Necrotizing; Fournier Gangrene

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nicolas de Prost, MD, PhD

  Service MIR, Hôpital Henri Mondor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas de Prost, MD, PhD

CONTACT

+33145178617; nicolasdeprost@gmail.com

Narimane Zeghbib

CONTACT

+33149814536; narimane.zeghbib@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Nicolas de Prost

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 11, 2021
• Study Start: November 8, 2021
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)