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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
15
Assistance Publique Hopitaux de Marseille
Marseille, France
RECRUITINGimprovement of the MHISS score
The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.
Time frame: 12 months
evaluate the effect of the procedure on quality of life
Health Assessment Questionnaire adapted to scleroderma, SHAQ
Time frame: 12 months
evaluate the effect of the procedure on face pain
face pain scale (VAS 0-100)
Time frame: 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)
Time frame: 12 months
evaluate the effect of the procedure on physical face changes
physical face changes is evaluated by standard and 3D photographs.
Time frame: 12 months
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