WoundPLAIES VITALESNCT02892526
Wound Vitality Markers in Forensic Pathology
An observational study of Wound, run by Central Hospital, Nancy, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- Abdominoplasty with exeresis of cutaneous tissue and Collection of cutaneous tissue
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Alive persons:
- Abdominoplasty
- Deceased persons:
- Medico-scientific autopsy for diagnosis
Who cannot join
- Alive persons:
- Fragmented sample with non-visible banks
- Cutaneous pathology
- Deceased persons:
- Persons under protection
- Medico-legal obstacle
- Cutaneous pathology
Trial locations and contacts
1 site in 1 country.
Laurent MARTRILLE contact
About this study
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
- Being tested
- Abdominoplasty with exeresis of cutaneous tissue, Collection of cutaneous tissue
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominoplasty with exeresis of cutaneous tissueOther
Collection of cutaneous tissueOther
| Study group | Role | What they receive |
|---|---|---|
| Vital wounds | from abdominoplasty of alive persons Receives: Other: Abdominoplasty with exeresis of cutaneous tissue | |
| Post-mortem wounds | from autopsy of deceased persons Receives: Other: Collection of cutaneous tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of markers for vitality diagnosis
Measured: baseline
Specificity of markers for vitality diagnosis
Measured: baseline
Secondary outcomes (5)
Minimum time to obtain a labeling (between incision and devascularization)
Measured: baseline
Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)
Measured: baseline
Expression level of miR 9 by qRT-PCR
Measured: baseline
Expression level of miR 21 by qRT-PCR
Measured: baseline
Expression level of miR 198 by qRT-PCR
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MARTRILLE, Principal investigator, Service de Médecine Légale - CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892526
- Sponsor's protocol ID
- 2012/CPRC/PLAIES VITALES/MART
- Acronym
- PLAIES VITALES
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Vitality Markers in Forensic Pathology
- ClinicalTrials.gov ID
- NCT02892526
- Acronym / sponsor ID
- PLAIES VITALES / 2012/CPRC/PLAIES VITALES/MART
- Conditions
- Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital wounds | – | Other: Abdominoplasty with exeresis of cutaneous tissuefrom abdominoplasty of alive persons |
| Post-mortem wounds | – | Other: Collection of cutaneous tissuefrom autopsy of deceased persons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Abdominoplasty
- Medico-scientific autopsy for diagnosis
Key exclusion criteria (7 listed)
- Fragmented sample with non-visible banks
- Cutaneous pathology
- Persons under protection
- Medico-legal obstacle
- Cutaneous pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominoplasty with exeresis of cutaneous tissue | Other | Vital wounds |
| Collection of cutaneous tissue | Other | Post-mortem wounds |
Primary outcome
Sensibility of markers for vitality diagnosis
Time frame: baseline
Specificity of markers for vitality diagnosis
Time frame: baseline
5 secondary outcomes
Minimum time to obtain a labeling (between incision and devascularization)
Time frame: baseline
Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)
Time frame: baseline
Expression level of miR 9 by qRT-PCR
Time frame: baseline
Expression level of miR 21 by qRT-PCR
Time frame: baseline
Expression level of miR 198 by qRT-PCR
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Wound
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent MARTRILLE contact
Laurent MARTRILLE principal investigator
Service de Médecine Légale - CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent MARTRILLE (l.martrille@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility of markers for vitality diagnosis (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.