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

NCT ID: NCT03669406

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-10-31

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.

Conditions

Eschar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autograft fat

Paraplegic patients with healed pelvic eschar

Group Type: EXPERIMENTAL

Autograft fat

Intervention Type: PROCEDURE

autograft fat

Interventions

Autograft fat

autograft fat

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie AILLET

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Cécile MEAL

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Rennes

Rennes, , France

Countries

France

Central Contacts

Pascal Gaudron

Role: CONTACT

drc@chu-rennes.fr

02 99 28 25 55

Anne Ganivet

Role: CONTACT

anne.ganivet@chu-rennes.fr

02 99 28 25 55

Facility Contacts

Cécile Méal

Role: primary

Other Identifiers

2017-A03022-51

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_8999_FATSCAR

Identifier Type: -

Identifier Source: org_study_id