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Identification of Biomarkers in the Legal Medical Skin Wounds

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Unknown status
CT.gov ID
NCT02898636
Collaborator
(none)
50
Enrollment
1
Location
42
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Mar 1, 2020

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ...)

Contacts and Locations

Locations

Site City State Country Postal Code
1 PEYRON Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02898636
Other Study ID Numbers:
  • 9552
First Posted:
Sep 13, 2016
Last Update Posted:
Aug 9, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Aug 9, 2019