Identification of Biomarkers in the Legal Medical Skin Wounds

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): 50

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • PEYRON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measures cytokines	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

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

Study record dates

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: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 9552 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED