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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)

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ClinicalTrials.gov Identifier: NCT03669406
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Eschar Procedure: Autograft fat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Autograft fat
Paraplegic patients with healed pelvic eschar
Procedure: Autograft fat
autograft fat




Primary Outcome Measures :
  1. Rate of recurrence of eschar [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Time of occurrence of recurrence of eschar (censored criterion) [ Time Frame: 12 months ]
  2. POSAS scale score [ Time Frame: 12 months ]
    Clinical evaluation

  3. Vancouver score [ Time Frame: 12 months ]
    Clinical evaluation

  4. Improvement Vancouver score [ Time Frame: 12 months ]
    Clinical evaluation

  5. Number of recurrence of eschar [ Time Frame: 12 months ]
    Clinical evaluation : non-recurrence

  6. Evaluation of neovascularization [ Time Frame: 12 months ]
    by Speckle laser doppler

  7. Volumetric assessment [ Time Frame: 12 months ]
    by contouring MRI

  8. Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat [ Time Frame: 12 months ]
    RNA PCR

  9. Analysis of the stromal vascular fraction of the injected fat [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669406


Contacts
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Contact: Pascal Gaudron 02 99 28 25 55 drc@chu-rennes.fr
Contact: Anne Ganivet 02 99 28 25 55 anne.ganivet@chu-rennes.fr

Locations
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France
CHU Rennes
Rennes, France
Contact: Cécile Méal         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Sylvie AILLET CHU Rennes
Principal Investigator: Cécile MEAL CHU Rennes
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03669406    
Other Study ID Numbers: 35RC17_8999_FATSCAR
2017-A03022-51 ( Other Identifier: N° ID-RCB )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Healed pelvic eschar
Paraplegic patient
Fat autograft