Identification of Biomarkers in the Legal Medical Skin Wounds

Legal Medical Skin Wounds Clinical Trial

Official title:

Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02898636
• Other study ID #: 9552
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2019
• Source: University Hospital, Montpellier
• Contact: Pierre-Antoine PEYRON, MD
• Phone: 467338586
• Email: pa-peyron[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 ...)

Related Conditions & MeSH terms

• Legal Medical Skin Wounds
• Wounds and Injuries

Intervention

Other:
• autopsy
At autopsy achieving adequate sampling of lesions and healthy skin

Locations

Country	Name	City	State
France	PEYRON	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measures cytokines	multiplex analysis electrochemoluminescence: Six cytokines candidates selected from a literature review (IFN-?, IL-1ß, IL-6, IL-10, IL-12 p70, TNF-a) 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.	1 day