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

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669406

Acronym

FATSCAR

Enrollment

Registered

2018-09-13

Start date

2020-09-01

Completion date

2021-10-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eschar

Keywords

Healed pelvic eschar, Paraplegic patient, Fat autograft

Brief summary

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.

Interventions

PROCEDUREAutograft fat

autograft fat

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of recurrence of eschar	12 months

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSylvie AILLET

Rennes University Hospital

PRINCIPAL_INVESTIGATORCécile MEAL