Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.

Study Overview
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Brief Summary
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Autografting of fat cells is widely used in plastic surgery in breast reconstruction, burn scars, unsightly scars etc. It is known that the autografting of fat cells not only makes it possible to bring adipocytes, and thus to create a volume, but also promotes neo-angiogenesis by providing the growth factors which allows an improvement of the local cutaneous tissue. Currently the investigators perform this action in their service on healed eschars, by analogy with burn scars that are also dystrophic, so as to improve cutaneous trophicity, and reduce the recurrence of eschars on these scars. However, the literature on the autografting of fat cells on eschars is limited.

Official Title
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Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.

Conditions
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Eschar

Intervention / Treatment
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* Procedure: Autograft fat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between 18 and 65 years old; presenting a medullary, post-traumatic or congenital lesion, with consequent paraplegic sequelae; With a history of eschar: Pelvic (ischiatic, trochanteric or sacral), Healed for at least 6 months, after surgical treatment or directed healing (scarring is defined by the absence of local care, ie no nursing care); Affiliated to a social security ; Written informed consent. Exclusion Criteria: Patient malnourished (albuminemia <40g / L); Non-weaning or weaned tobacco addiction for less than 3 weeks (compared to the date of surgery); Contraindication to MRI ; Protected person subject to legal protection (legal safeguards, guardianship, trusteeship), person deprived of liberty, Pregnant woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autograft fat<br>Paraplegic patients with healed pelvic eschar | Procedure: Autograft fat<br>* autograft fat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of eschar |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of occurrence of recurrence of eschar (censored criterion) |  | 12 months | 
| POSAS scale score | Clinical evaluation | 12 months | 
| Vancouver score | Clinical evaluation | 12 months | 
| Improvement Vancouver score | Clinical evaluation | 12 months | 
| Number of recurrence of eschar | Clinical evaluation : non-recurrence | 12 months | 
| Evaluation of neovascularization | by Speckle laser doppler | 12 months | 
| Volumetric assessment | by contouring MRI | 12 months | 
| Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat | RNA PCR | 12 months | 
| Analysis of the stromal vascular fraction of the injected fat |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healed pelvic eschar, Paraplegic patient, Fat autograft