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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02206672
Other study ID # 2014-A01014-43
Secondary ID 2014-12
Status Recruiting
Phase N/A
First received July 31, 2014
Last updated November 4, 2015
Start date July 2014
Est. completion date November 2015

Study information

Verified date September 2015
Source Assistance Publique Hopitaux De Marseille
Contact brigitte GRANEL
Email brigitte.granel@ap-hm.fr
Is FDA regulated No
Health authority France: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Other:
Micro reinjection of autologus adipose tissue


Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary evaluate the effect of the procedure on quality of life Health Assessment Questionnaire adapted to scleroderma, SHAQ 12 months No
Secondary evaluate the effect of the procedure on face pain face pain scale (VAS 0-100) 12 months No
Secondary 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 No
Secondary evaluate the effect of the procedure on physical face changes physical face changes is evaluated by standard and 3D photographs. 12 months No
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