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Identification of Biomarkers in the Legal Medical Skin Wounds

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ClinicalTrials.gov Identifier: NCT02898636
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Legal Medical Skin Wounds 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
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient undergoing a forensic autopsy
Criteria

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 ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898636


Contacts
Contact: Pierre-Antoine PEYRON, MD 467338586 ext 33 pa-peyron@chu-montpellier.fr

Locations
France
PEYRON Recruiting
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Director: Pierre-Antoine PEYRON, MD University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02898636     History of Changes
Other Study ID Numbers: 9552
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Wounds and Injuries