NCT02898636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

September 8, 2016

Last Update Submit

August 8, 2019

Conditions

Legal Medical Skin Wounds

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

autopsyOTHER

At autopsy achieving adequate sampling of lesions and healthy skin

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient undergoing a forensic autopsy

You may qualify if:

  • 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)

You may not qualify if:

  • Immunocompromised patients (HIV infection, immunosuppressive therapy ...)
  • Putrefaction signs (abdominal patch of green ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PEYRON

Montpellier, 34295, France

RECRUITING

MeSH Terms

Interventions

Autopsy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Pierre-Antoine PEYRON, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Pierre-Antoine PEYRON, MD

CONTACT

467338586pa-peyron@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

FR(1)