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

Eschar Clinical Trial

— FATSCAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03669406
• Other study ID #: 35RC17_8999_FATSCAR
• Secondary ID: 2017-A03022-51
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: October 2021

Study information

• Verified date: June 2020
• Source: Rennes University Hospital
• Contact: Pascal Gaudron
• Phone: 02 99 28 25 55
• Email: drc[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eschar

Intervention

Procedure:
• Autograft fat
autograft fat

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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