Wound Vitality Markers in Forensic Pathology

NCT02892526 | Unknown

• 1 other identifier: 2012/CPRC/PLAIES VITALES/MART
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Outcome Measures

Primary Outcomes (2)

• Sensibility of markers for vitality diagnosis

  baseline

• Specificity of markers for vitality diagnosis

  baseline

Secondary Outcomes (5)

• Minimum time to obtain a labeling (between incision and devascularization)

  baseline

• Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)

  baseline

• Expression level of miR 9 by qRT-PCR

  baseline

• Expression level of miR 21 by qRT-PCR

  baseline

• Expression level of miR 198 by qRT-PCR

  baseline

Study Arms (2)

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

Interventions

Abdominoplasty with exeresis of cutaneous tissue OTHER

Vital wounds

Collection of cutaneous tissue OTHER

Post-mortem wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Alive persons:
• \- Abdominoplasty
• Deceased persons:
• \- Medico-scientific autopsy for diagnosis

You may not qualify if:

• Alive persons:
• Fragmented sample with non-visible banks
• Cutaneous pathology
• Deceased persons:
• Persons under protection
• Medico-legal obstacle
• Cutaneous pathology

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cutaneous tissue

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Abdominoplasty

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Laurent MARTRILLE

  Service de Médecine Légale - CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent MARTRILLE

CONTACT

l.martrille@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)