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


- candidate number22496
- NTR NumberNTR5325
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2015
- Secondary IDsMETc 2014/500 METc UMCG
- Public TitlePredictors of the volumetric outcome and patients' satisfaction of facial fat grafting.
- Scientific TitlePredictors of the volumetric outcome and patients' satisfaction of facial fat grafting.
- ACRONYMLIPOFILLING
- hypothesisAutologous 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. This study aims to relate patientís bodyweight, smoking habits, estradiol level and the post-menopausal status to the volumetric outcome and satisfaction of patients after facial fat grafting. The hypothesis is that smoking and low estradiol levels will influence the volumetric outcome negatively.
- Healt Condition(s) or Problem(s) studiedSatisfaction, Lipofilling
- Inclusion criteriaWomen
Age between 18 and 75 years
Facial fat graft procedure at the department of Oral
Maxillofacial surgery in the University Medical Center Groningen
- Exclusion criteriaChildren (under 18 years)
Men
Patients 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-feb-2020
- Target number of participants100
- InterventionsFacial fat grafting
- Primary outcomeVolumetric differences between baseline and 1 year after fat grafting measured by 3d stereophotogrammetry
- Secondary outcomePatient satisfaction measured by FACE-Q questionnaire
- TimepointsPreoperative (4-6 weeks preoperatively)
1 week postoperatively
6 weeks postoperatively
6 months postoperatively
12 months postoperatively
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD A.J. Tuin
- CONTACT for SCIENTIFIC QUERIESMD A.J. Tuin
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Oral and Maxillofacial Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen; department of Oral and Maxillofacial Surgery
- Publications-
- Brief summaryAutologous 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. This study aims to relate patientís bodyweight, smoking habits, estradiol level and the post-menopausal status to the volumetric outcome and satisfaction of patients after facial fat grafting. The design of the study is a prospective observational cohort study with invasive measurements.
All patients who will undergo a facial fat graft procedure at the department of Oral and Maxillofacial Surgery at the University Medical Center Groningen (the Netherlands) will be included.
Volumetric outcome will be measured by 3D stereophotogrammetry at 6 weeks, 6 months, and 12 months. Patient satisfaction will be evaluated by the FACE-Q questionnaire. 17b oestradiol and AMH measurements will be generalized using a blood sample. Burden risk of participation the study thought to be very low.
- Main changes (audit trail)
- RECORD23-jul-2015 - 24-aug-2015


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