Improving diagnosis of severe soft tissue infections in the emergency room

Biomarker-based diagnosis of severe soft tissue infections in the emergency room

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN98460139

Enrollment

400

Registered

2025-10-17

Start date

2025-10-20

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prospective validation of the diagnostic potential of biomarkers for severe soft tissue infections in the emergency ward Skin and Connective Tissue Diseases

Interventions

Blood samples will be drawn in the emergency ward. The patients will be informed about the study and asked for consent during their hospital stay. Health data from the hospital stay will be gathered f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) in the emergency ward where there is clinical suspicion of necrotizing soft tissue infection with at least one of the following symptoms and signs: 1. Disproportionate pain 2. Rapid spreading of redness, swelling/induration or blisters 3. Hypotension with a mean arterial pressure of less than 65 mmHg 4. Clinical suspicion by the attending physician prompting a consult with orthopaedics or an infection specialist

Exclusion criteria

Exclusion criteria: The patient doesn't want to participate in the study

Design outcomes

Primary

Measure	Time frame
The accuracy of Thrombomodulin as a diagnostic marker for NSTI assessed by AUC, sensitivity, and specificity. Thrombomodulin concentration will be measured on samples taken at admission to the emergency department and analysed with standard techniques such as ELISA and/or CLIA. Thrombomodulin concentrations will be compared between patients with and without NSTI, based on exploratory surgery findings.	—

Measure

Time frame

The accuracy of Thrombomodulin as a diagnostic marker for NSTI assessed by AUC, sensitivity, and specificity. Thrombomodulin concentration will be measured on samples taken at admission to the emergency department and analysed with standard techniques such as ELISA and/or CLIA. Thrombomodulin concentrations will be compared between patients with and without NSTI, based on exploratory surgery findings.

—

Secondary

Measure	Time frame
The accuracy of a panel of plasma biomarkers in detecting aetiology and risk of severe disease in patients with severe soft tissue infections assessed by AUC, sensitivity, and specificity. Protein concentrations will be measured on samples taken at admission to the emergency department, and analysed with standard techniques such as ELISA, CLIA and/or Multiplex Luminex. Biomarker concentrations will be compared across patients with varying disease severity and different bacterial sources of infection	—

Measure

Time frame

The accuracy of a panel of plasma biomarkers in detecting aetiology and risk of severe disease in patients with severe soft tissue infections assessed by AUC, sensitivity, and specificity. Protein concentrations will be measured on samples taken at admission to the emergency department, and analysed with standard techniques such as ELISA, CLIA and/or Multiplex Luminex. Biomarker concentrations will be compared across patients with varying disease severity and different bacterial sources of infection

—

Countries

Sweden

Contacts

Public ContactAnna-Karin Nilsson

anna-karin.m.nilsson@regionstockholm.se+46812355000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026