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WithdrawnNCT03669406FATSCARUpdated Jun 15, 2026

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

An interventional study of Autograft fat in Eschar, sponsored by Rennes University Hospital. Withdrawn at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
a project that did not get off the ground because the authorisation had expired
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Eschar

Keywords

  • Healed pelvic eschar
  • Paraplegic patient
  • Fat autograft
03

In context

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Autograft fat

    Paraplegic patients with healed pelvic eschar

    Procedure: Autograft fat

Interventions

  • ProcedureAutograft fat

    autograft fat

06

What researchers measure

Primary outcomes

  1. Rate of recurrence of eschar

    Time frame: 12 months

Secondary outcomes

  1. Time of occurrence of recurrence of eschar (censored criterion)

    Time frame: 12 months

  2. POSAS scale score

    Clinical evaluation

    Time frame: 12 months

  3. Vancouver score

    Clinical evaluation

    Time frame: 12 months

  4. Improvement Vancouver score

    Clinical evaluation

    Time frame: 12 months

  5. Number of recurrence of eschar

    Clinical evaluation : non-recurrence

    Time frame: 12 months

  6. Evaluation of neovascularization

    by Speckle laser doppler

    Time frame: 12 months

  7. Volumetric assessment

    by contouring MRI

    Time frame: 12 months

  8. Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat

    RNA PCR

    Time frame: 12 months

  9. Analysis of the stromal vascular fraction of the injected fat

    Time frame: 12 months

07

Study locations

1 site
  • CHU Rennes
    Rennes, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03669406
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Sep 2020 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Jun 15, 2026

Study contacts

Sylvie AILLET
principal investigator · Rennes University Hospital
Cécile MEAL
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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