Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
FATSCAR
2 other identifiers
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedJune 9, 2020
June 1, 2020
1 year
September 10, 2018
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of recurrence of eschar
12 months
Secondary Outcomes (9)
Time of occurrence of recurrence of eschar (censored criterion)
12 months
POSAS scale score
12 months
Vancouver score
12 months
Improvement Vancouver score
12 months
Number of recurrence of eschar
12 months
- +4 more secondary outcomes
Study Arms (1)
Autograft fat
EXPERIMENTALParaplegic patients with healed pelvic eschar
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Rennes
Rennes, France
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie AILLET
CHU Rennes
- PRINCIPAL INVESTIGATOR
Cécile MEAL
CHU Rennes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 13, 2018
Study Start
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share