EscharFATSCARNCT03669406
Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
A study testing Autograft fat in people with Eschar, run by Rennes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eschar
- What is being tested?
- Autograft fat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Autograft fat
- Keywords
- Healed pelvic eschar, Paraplegic patient, Fat autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autograft fatProcedure or surgery
autograft fat
| Study group | Role | What they receive |
|---|---|---|
| Autograft fat | Experimental | Paraplegic patients with healed pelvic eschar Receives: Procedure: Autograft fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence of eschar
Measured: 12 months
Secondary outcomes (9)
Time of occurrence of recurrence of eschar (censored criterion)
Measured: 12 months
POSAS scale score
Clinical evaluation
Measured: 12 months
Vancouver score
Clinical evaluation
Measured: 12 months
Improvement Vancouver score
Clinical evaluation
Measured: 12 months
Number of recurrence of eschar
Clinical evaluation : non-recurrence
Measured: 12 months
Evaluation of neovascularization
by Speckle laser doppler
Measured: 12 months
Volumetric assessment
by contouring MRI
Measured: 12 months
Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat
RNA PCR
Measured: 12 months
Analysis of the stromal vascular fraction of the injected fat
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: a project that did not get off the ground because the authorisation had expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EscharStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie AILLET, Principal investigator, Rennes University HospitalCécile MEAL, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669406
- Sponsor's protocol ID
- 35RC17_8999_FATSCAR
- Other IDs
- 2017-A03022-51
- Acronym
- FATSCAR
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
- ClinicalTrials.gov ID
- NCT03669406
- Acronym / sponsor ID
- FATSCAR / 35RC17_8999_FATSCAR
- Conditions
- Eschar
- Keywords
- Healed pelvic eschar, Paraplegic patient, Fat autograft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: a project that did not get off the ground because the authorisation had expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autograft fat | Experimental | Procedure: Autograft fatParaplegic patients with healed pelvic eschar |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient between 18 and 65 years old;
- presenting a medullary, post-traumatic or congenital lesion, with consequent paraplegic sequelae;
- With a history of eschar:
- Affiliated to a social security ;
- Written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autograft fatautograft fat | Procedure or surgery | Autograft fat |
Primary outcome
Rate of recurrence of eschar
Time frame: 12 months
9 secondary outcomes
Time of occurrence of recurrence of eschar (censored criterion)
Time frame: 12 months
POSAS scale score
Time frame: 12 months
Vancouver score
Time frame: 12 months
Improvement Vancouver score
Time frame: 12 months
Number of recurrence of eschar
Time frame: 12 months
Evaluation of neovascularization
Time frame: 12 months
Volumetric assessment
Time frame: 12 months
Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat
Time frame: 12 months
Analysis of the stromal vascular fraction of the injected fat
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie AILLET principal investigator
Rennes University Hospital
Cécile MEAL principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autograft fat in people with Eschar, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence of eschar (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.