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

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.

Study Overview

• Status: Unknown
• Conditions: Eschar
• Intervention / Treatment: Procedure: Autograft fat

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal Gaudron; Phone Number: 02 99 28 25 55; Email: drc@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • CHU Rennes
    • Contact: Cécile Méal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autograft fat; Paraplegic patients with healed pelvic eschar	Procedure: Autograft fat; autograft fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Sylvie AILLET, CHU Rennes; Principal Investigator: Cécile MEAL, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Healed pelvic eschar; Paraplegic patient; Fat autograft
• Other Study ID Numbers: 35RC17_8999_FATSCAR; 2017-A03022-51 (Other Identifier: N° ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No