Identification of Biomarkers in the Legal Medical Skin Wounds

• Conditions: Legal Medical Skin Wounds

• Registration Number: NCT02898636
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Detailed Description

Determining the vitality of skin wounds, that is to say their antemortem character, is an important issue in forensic pathology. The only criterion vitality currently recognized (but whose diagnostic performance remains limited) is the microscopic demonstration of an inflammatory infiltrate of neutrophils. The search for more reliable diagnostic biomarkers is required. By their early expression of the injury site, inflammatory cytokines are potential candidates and their quantification in injured skin could optimize the diagnosis of vitality injury.

The objective is to identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09
• Primary Completion: 2019-12-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult died 18 years or more
• Having at least one recent ante-mortem skin wound (occurring less than 4 hours prior to death)
• Hours of death and the establishment of the ante-mortem wound known (date, hours and minutes)

Exclusion Criteria

• Immunocompromised patients (HIV infection, immunosuppressive therapy ...)
• Putrefaction signs (abdominal patch of green ...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measures cytokines	1 day	multiplex analysis electrochemoluminescence: Six cytokines candidates selected from a literature review (IFN-γ, IL-1β, IL-6, IL-10, IL-12 p70, TNF-α) will be assayed in conjunction with the MSD technology (V-PLEX proinflammatory Panel 1 human Kit) after tissue extraction and determination of total protein concentration in each sample.

Trial Locations

Locations (1)

PEYRON; 🇫🇷 Montpellier, France