Identification of Biomarkers in the Legal Medical Skin Wounds

August 8, 2019 updated by: University Hospital, Montpellier

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

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 Overview

Status

Unknown

Conditions

Legal Medical Skin Wounds

Intervention / Treatment

Other: autopsy

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 Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Montpellier, France, 34295
    - Recruiting
    - PEYRON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient undergoing a forensic autopsy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measures cytokines Time Frame: 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.	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

Study Director: Pierre-Antoine PEYRON, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria