EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- improvement of the MHISS score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Less than 18 or greater than 80 age.
- •Decaying history of abdominal surgery.
- •Body mass index lower than
- •Coagulation disorders.
- •Allergy to Xylocaine.
- •Greater than 20mg / d steroids.
- •Severe infection.
- •Pregnant women.
- •Adults protected by law (under guardianship and trusteeship).
- •No affiliation to a social security scheme.
结局指标
主要结局
improvement of the MHISS score
时间窗: 12 months
The MHISS questionnaire is chosen as it specifically assesses disability involving the mouth and the face in SSc patients.
次要结局
- evaluate the effect of the procedure on quality of life(12 months)
- evaluate the effect of the procedure on face pain(12 months)
- evaluate the effect of the procedure on physical face changes(12 months)
- evaluate the effect of the procedure on skin fibrosis(12 months)