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

R

Rennes University Hospital

Status

Unknown

Conditions

Eschar

Treatments

Procedure: Autograft fat

Study type

Interventional

Funder types

Other

Identifiers

NCT03669406
2017-A03022-51 (Other Identifier)
35RC17_8999_FATSCAR

Details and patient eligibility

About

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.

Enrollment

27 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Autograft fat
Experimental group
Description:
Paraplegic patients with healed pelvic eschar
Treatment:
Procedure: Autograft fat

Trial contacts and locations

1

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Central trial contact

Pascal Gaudron; Anne Ganivet

Data sourced from clinicaltrials.gov

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