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)
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a case report, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health. Reported size: 1,033 participants or records.
Read the paper
Related studies
- Understanding the factors influencing fall armyworm (Spodoptera frugiperda J.E. Smith) damage in African smallholder maize fields and quantifying its impact on yield. A case study in Eastern Zimbabwe
- Alarming situation of emerging H5 and H7 avian influenza and effective control strategies
- Livestock and food security: vulnerability to population growth and climate change
- Atmosphere–ocean oxygen and productivity dynamics during early animal radiations
- Characterization of the global distribution and diversified plasmid reservoirs of the colistin resistance gene mcr-9
- The global seroprevalence of Toxoplasma gondii in pigs: A systematic review and meta-analysis
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.