Informations générales (source: ClinicalTrials.gov)
EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS (FACE)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
juillet 2014
novembre 2015
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | BRIGITTE GRANEL | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.