The first objective of this study is to assess the volumetric changes from baseline one year after fat grafting measured by 3d stereophotogrammetry (3dMD). The observed level of fat retention will be related to injected volume, bodyweight, smoking…
ID
Source
Brief title
Condition
- Age related factors
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is volumetric changes from baseline to one year after fat
grafting measured by 3d stereophotogrammetry and calculated using 3D software.
All the patients will get series of 3D photographs of the face preoperatively
(baseline) and twelve months postoperatively. The injected volume during the
fat graft procedure will be noted. The change in volume measured by 3d
stereophotogrammetry will be related to injected volume, bodyweight, smoking
habits, 17ß oestradiol level and/or the post-menopausal state.
Secondary outcome
The secondary objectives are:
* patient satisfaction about their facial appearance, psychological wellbeing
and social function preoperatively, and after 1 week, 6 weeks, 6 months, and 12
months after the procedure measured by the validated FACE-Q questionnaire.
* the evaluation of volumetric changes during the follow up measured at 6
weeks, 6 months, and 12 months.
* relation of patients* satisfaction and the volumetric outcome of their facial
fat graft measured by 3d stereophotogrammetry at different time points.
Background summary
Autologous fat grafts are commonly used in reconstructive and aesthetic
surgery. The retention of the transplanted fat is 20-90%. The predictors of
this volume retention remain unclear.
Study objective
The first objective of this study is to assess the volumetric changes from
baseline one year after fat grafting measured by 3d stereophotogrammetry
(3dMD). The observed level of fat retention will be related to injected volume,
bodyweight, smoking habits, 17ß oestradiol level and/or the post-menopausal
state. The second objective is to assess the change in patient satisfaction by
a (translated) validated questionnaire (FACE-Q).
Study design
This study is a prospective cohort study.
Study burden and risks
The burden and risks for patients who will join this research project are
thought to be very low if any. The burden for the patient is to complete short
questionnaires and to undergo one extra blood draw (one tube) at baseline.
The benefits from this research project are that new insights will be obtained
how to make reliable surgical plans in the future. Moreover, patients will be
better informed on forehand about the expected results of fat grafting in
advance.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51511.042.14 |