Wound Vitality Markers in Forensic Pathology (PLAIES VITALES)

September 2, 2016 updated by: Central Hospital, Nancy, France

The purpose is to determine intrinsic properties of various immunohistochemical markers (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound, alone and in association (evaluation of sensibility with surgery wounds and evaluation of specificity with post-mortem wounds).

Secondary purposes are to measure the minimum time to obtain a positive labeling in vital wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

57

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
      • Nancy, France
        • Recruiting
        • CHRU NANCY

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated in Plastic and Reconstructive Surgery and Maxillofacial Surgery departments at CHRU Nancy for therapeutic abdominoplasty.

Deceased patients, whose medico-scientific autopsies are performed for diagnosis in Anatomy and Pathological Cytology or Legal Medicine departments.

Description

Inclusion Criteria:

Alive persons:

- Abdominoplasty

Deceased persons:

- Medico-scientific autopsy for diagnosis

Exclusion Criteria:

Alive persons:

  • Fragmented sample with non-visible banks
  • Cutaneous pathology

Deceased persons:

  • Persons under protection
  • Medico-legal obstacle
  • Cutaneous pathology

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vital wounds
from abdominoplasty of alive persons
Other: Abdominoplasty with exeresis of cutaneous tissue
Post-mortem wounds
from autopsy of deceased persons
Other: Collection of cutaneous tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensibility of markers for vitality diagnosis
Time Frame: baseline
baseline
Specificity of markers for vitality diagnosis
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimum time to obtain a labeling (between incision and devascularization)
Time Frame: baseline
baseline
Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)
Time Frame: baseline
baseline
Expression level of miR 9 by qRT-PCR
Time Frame: baseline
baseline
Expression level of miR 21 by qRT-PCR
Time Frame: baseline
baseline
Expression level of miR 198 by qRT-PCR
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Laurent MARTRILLE, Service de Médecine Légale - CHRU de Nancy

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/CPRC/PLAIES VITALES/MART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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