CompletedNot Applicable

Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study

Denmark260 participantsStarted 2013-02

Plain-language summary

The investigators will analyze biomarkers related to the prognosis and treatment of necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial and immune system biomarkers can function as markers of disease severity, mortality as well as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon admission to an intensive care unit at Copenhagen University Hospital and during the following 3 days.

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 for NSTI patients (both of which must be met): * Diagnosed with NSTI based on surgical findings (necrosis of any soft tissue compartment; dermis, hypodermis, fascia or muscle) * Admitted to the Intensive Care Unit (ICU) and/or operated for NSTI at Copenhagen University Hospital Exclusion Criteria for NSTI patients: * They are categorized as non NSTI in the operating theatre Inclusion criteria for orthopaedic control patients: * Undergoing elective orthopedic surgery (non-pathological fractures, joint replacement surgery or spine surgery) at Copenhagen University Hospital Exclusion criteria for orthopaedic control patients: * Ongoing infection or inflammatory condition

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.

What they're measuring

sTM and sE-selectin as biomarkers of HBOT effect in NSTI patients

Timeframe: At admission, and during the next 3 days in the ICU

suPAR as a biomarker of disease severity and prognosis in NSTI patients with and without septic shock

Timeframe: At admission

Trial details

NCT IDNCT03147352

SponsorOle Hyldegaard

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-01

View on ClinicalTrials.gov More Necrotizing Soft Tissue Infection trials