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Wound Vitality Markers in Forensic Pathology (PLAIES VITALES)

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ClinicalTrials.gov Identifier: NCT02892526
Recruitment Status : Unknown
Verified September 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

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.


Condition or disease Intervention/treatment
Wound Other: Abdominoplasty with exeresis of cutaneous tissue Other: Collection of cutaneous tissue

Study Type : Observational
Estimated Enrollment : 57 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Wound Vitality Markers in Forensic Pathology
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Sensibility of markers for vitality diagnosis [ Time Frame: baseline ]
  2. Specificity of markers for vitality diagnosis [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Minimum time to obtain a labeling (between incision and devascularization) [ Time Frame: baseline ]
  2. Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis) [ Time Frame: baseline ]
  3. Expression level of miR 9 by qRT-PCR [ Time Frame: baseline ]
  4. Expression level of miR 21 by qRT-PCR [ Time Frame: baseline ]
  5. Expression level of miR 198 by qRT-PCR [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
Cutaneous tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

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): NCT02892526


Contacts
Contact: Laurent MARTRILLE l.martrille@chru-nancy.fr

Locations
France
CHRU Nancy Recruiting
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Laurent MARTRILLE Service de Médecine Légale - CHRU de Nancy

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02892526     History of Changes
Other Study ID Numbers: 2012/CPRC/PLAIES VITALES/MART
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries