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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-12 | Other Identifier | AP HM |
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This prospective single-center study evaluates a current care procedure. It includes 14 patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48), a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.
Micro fat grafting is a minimally invasive and usual procedure performed under local anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter cannula from areas around the knees, the abdomen or the hips under a gentle aspiration. Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed, single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25 milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry points located around the mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro reinjection of autologus adipose tissue | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro reinjection of autologus adipose tissue | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement of the MHISS score | The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the effect of the procedure on quality of life | Health Assessment Questionnaire adapted to scleroderma, SHAQ | 12 months |
| evaluate the effect of the procedure on face pain | face pain scale (VAS 0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| brigitte GRANEL | Contact | brigitte.granel@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| brigitte GRANEL, MD | AP HM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | 13354 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| 12 months |
| evaluate the effect of the procedure on skin fibrosis | skin fibrosis is measured by Rodnan skin score for the face, mouth opening measure and cutometry) | 12 months |
| evaluate the effect of the procedure on physical face changes | physical face changes is evaluated by standard and 3D photographs. | 12 months |