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

Not Applicable

• Conditions: Eschar
• Interventions: Procedure: Autograft fat

• Registration Number: NCT03669406
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-09
• Study Start: 2020-09
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autograft fat	Autograft fat	Paraplegic patients with healed pelvic eschar

Primary Outcome Measures

Name	Time	Method
Rate of recurrence of eschar	12 months

Secondary Outcome Measures

Name	Time	Method
Vancouver score	12 months	Clinical evaluation
POSAS scale score	12 months	Clinical evaluation
Improvement Vancouver score	12 months	Clinical evaluation
Evaluation of neovascularization	12 months	by Speckle laser doppler
Analysis of the stromal vascular fraction of the injected fat	12 months
Time of occurrence of recurrence of eschar (censored criterion)	12 months
Number of recurrence of eschar	12 months	Clinical evaluation : non-recurrence
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

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France