Systemic Sclerosis
Conditions
Brief summary
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.
Interventions
OTHERMicro reinjection of autologus adipose tissue
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 or younger than 80 years. * Suffering from systemic scleroderma. * Patient follow-AP-HM. * Score of 20 or greater MHISS. * Score Rodnan level greater than or equal to one face. * Mouth opening (inter-incisor distance) \<5.5 cm * Wishing to receive surgery at the face.
Exclusion criteria
* Less than 18 or greater than 80 age. * Decaying history of abdominal surgery. * Body mass index lower than 18. * Coagulation disorders. * Allergy to Xylocaine. * Greater than 20mg / d steroids. * Severe infection. * Inmates. * Pregnant women. * Adults protected by law (under guardianship and trusteeship). * No affiliation to a social security scheme.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement of the MHISS score | 12 months | The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the effect of the procedure on quality of life | 12 months | Health Assessment Questionnaire adapted to scleroderma, SHAQ |
| evaluate the effect of the procedure on face pain | 12 months | face pain scale (VAS 0-100) |
| evaluate the effect of the procedure on skin fibrosis | 12 months | skin fibrosis is measured by Rodnan skin score for the face, mouth opening measure and cutometry) |
| evaluate the effect of the procedure on physical face changes | 12 months | physical face changes is evaluated by standard and 3D photographs. |
Countries
France
Contacts
Primary Contactbrigitte GRANEL
Outcome results
None listed