Wound Vitality Markers in Forensic Pathology

Wound Clinical Trial

— PLAIES VITALES  

Official title:

Wound Vitality Markers in Forensic Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892526
• Other study ID #: 2012/CPRC/PLAIES VITALES/MART
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2016
• Last updated: September 2, 2016
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: Laurent MARTRILLE
• Email: l.martrille[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Wound
• Wounds and Injuries

Intervention

Other:
• Abdominoplasty with exeresis of cutaneous tissue

• Collection of cutaneous tissue

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility of markers for vitality diagnosis		baseline	No
Primary	Specificity of markers for vitality diagnosis		baseline	No
Secondary	Minimum time to obtain a labeling (between incision and devascularization)		baseline	No
Secondary	Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)		baseline	No
Secondary	Expression level of miR 9 by qRT-PCR		baseline	No
Secondary	Expression level of miR 21 by qRT-PCR		baseline	No
Secondary	Expression level of miR 198 by qRT-PCR		baseline	No