Mortality, functional outcome and health-related quality of life in patients with necrotizing skin- and soft tissue infections in the ICU: Protocol of a multinational prospective cohort study (SKIN-ICU)

Other authors

Institut Català de la Salut

[Urbina T] Medical Intensive Care Unit Hôpital Saint-Antoine Assistance Publique-Hôpitaux de Paris, Paris, France. [Madsen MB] Department of Intensive Care Copenhagen University Hospital Rigshospitalet Copenhagen, Denmark. Department of Cardiothoracic Anaesthesia and Intensive Care The Heart Center Copenhagen University Hospital Rigshospitalet Copenhagen, Denmark. [Hua C] Department of Dermatology Hôpital Henri-Mondor Assistance Publique-Hôpitaux de Paris Créteil, France. EpiDermE - EA 7379 UPEC Créteil, France. [Eckmann C] Department of General Visceral and Thoracic Surgery Klinikum Hannoversch-Muenden Goettingen University, Germany. [Elhadi M] Faculty of Medicine University of Tripoli, Libya. [Gurjar M] Department of Critical Care Medicine Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, India. [Ferrer Rocca R] Servei de Medicina Intensiva, Vall d’Hebron Hospital Universitari, Barcelona, Spain

Vall d'Hebron Barcelona Hospital Campus

Publication date

2025-03-21T09:43:56Z

2025-03-21T09:43:56Z

2025-03



Abstract

Adult intensive & critical care; Adult surgery; Necrotizing soft tissue infections


Cuidados intensivos y críticos para adultos; Cirugía de adultos; Infecciones necrosantes de tejidos blandos


Cures intensives i crítiques per a adults; Cirurgia d'adults; Infeccions necrotitzants de teixits tous


Background Necrotizing soft tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by necrosis of subcutaneous tissue, fascia, or muscle. Few prospective studies have been conducted. The primary objective is to assess the 90-day mortality rate and to identify prognostic factors in patients with NSTI in an international setting. Secondary objectives are i) to characterize the clinical and microbiological presentation and management; ii) to assess the risk of limb amputation and associated factors; and iii) to assess functional and health-related quality of life (HRQoL) outcomes and associated factors. Methods We are conducting a multinational, prospective, non-interventional cohort study. We plan to enroll 1,033 consecutive patients admitted to 85 hospitals with surgically proven NSTI between November 2021 and December 2024 in 17 countries over three continents. Data will be collected prospectively on a secure web-based server. The primary outcome measure will be the day-90 mortality. Secondary outcomes include need for limb amputation, the activity of daily living scale and health-related quality of life at day-90 (EQ-5D-5L questionnaire). Baseline characteristics associated with outcomes will be identified by multivariable analyses. Exploratory analyses will be conducted to assess the impact of therapeutic interventions on day-90 mortality and secondary outcomes. The study protocol has been approved by an ethics committee in each participating country.


This work was supported by the European Society of Intensive Care Medicine (ESICM) 2020 Next Start-up grant.

Document Type

Article


Published version

Language

English

Publisher

Elsevier

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Attribution 4.0 International

http://creativecommons.org/licenses/by/4.0/

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