Predictors of the volumetric outcome and patients' satisfaction of facial fat grafting.

Completed

Conditions: autologous fat transplantation
fat graft
lipofilling
10001474
10040795

Registration Number: NL-OMON41719

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

Inclusion Criteria

Women
Age between 18 and 75 year
Facial fat graft procedure at the department of Oral Maxillofacial surgery of the University Medical Center Groningen

Exclusion Criteria

Children (<18 years)
Men
Patient older than 75 years
Pregnancy at the moment of the fat graft procedure
Contraindications for fat grafting: ASA class 3 or 4, coagulation disorders, body dismorphic disorder, use of anticoagulantia what can not be stopped for this procedure, medication with interference with cytochroom P450, 3A4 or 1A2

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is volumetric changes from baseline to one year after fat<br /><br>grafting measured by 3d stereophotogrammetry and calculated using 3D software.<br /><br>All the patients will get series of 3D photographs of the face preoperatively<br /><br>(baseline) and twelve months postoperatively. The injected volume during the<br /><br>fat graft procedure will be noted. The change in volume measured by 3d<br /><br>stereophotogrammetry will be related to injected volume, bodyweight, smoking<br /><br>habits, 17ß oestradiol level and/or the post-menopausal state.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are:<br /><br>* patient satisfaction about their facial appearance, psychological wellbeing<br /><br>and social function preoperatively, and after 1 week, 6 weeks, 6 months, and 12<br /><br>months after the procedure measured by the validated FACE-Q questionnaire.<br /><br>* the evaluation of volumetric changes during the follow up measured at 6<br /><br>weeks, 6 months, and 12 months.<br /><br>* relation of patients* satisfaction and the volumetric outcome of their facial<br /><br>fat graft measured by 3d stereophotogrammetry at different time points. </p><br>