SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-natio… (NCT05116956) | Clinical Trial Compass
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SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study
France1,033 participantsStarted 2021-11-08
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Patient deprived of liberty by judicial or administrative decision or patient under guardianship
* Expressed opposition to project's participation at the project
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.