Clinical trial NCT03669406: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
Official title: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eschar
Keywords: Healed pelvic eschar
Paraplegic patient
Fat autograft
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of recurrence of eschar
timeFrame: 12 months
Secondary outcomes:
measure: Time of occurrence of recurrence of eschar (censored criterion)
timeFrame: 12 months
measure: POSAS scale score
timeFrame: 12 months
measure: Vancouver score
timeFrame: 12 months
measure: Improvement Vancouver score
timeFrame: 12 months
measure: Number of recurrence of eschar
timeFrame: 12 months
measure: Evaluation of neovascularization
timeFrame: 12 months
measure: Volumetric assessment
timeFrame: 12 months
measure: Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat
timeFrame: 12 months
measure: Analysis of the stromal vascular fraction of the injected fat
timeFrame: 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Sylvie AILLET
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Cécile MEAL
role: PRINCIPAL_INVESTIGATOR
References: