atrophy of the skin Loss of skin quality loss of volume
Conditions
Interventions
The Colemen technique for fat harvesting and injection is employed but refined
by utilising a smaller, custom-made cannula for harvesting (inner diameter,
1,3mm). The upper legs are donor sites. 3/4
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Females - Aged 35-60 - Stable normal BMI (20-25) (1 year stable between 20-25)
Exclusion criteria
Exclusion criteria: • Male • Aged below 35 or above 60 years • Surgical interventions of the face in the year prior to the date of surgery • Any oncological event in the patients history • A known psychiatric condition • A known systemic disease that will impair wound healing (e.g. diabetes mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin). • Smoking • 20
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative skin quality measured with a Multi Probe Adapter system (Courage Khanza Colone Germany) containing two skin measurement probes (Cutometer MPA580: Mechanical parameters of the skin and Tewameter TM300: Skin barrier function and transepidermal waterloss,) on predetermined fixed positions in the face on predetermined times (preoperative, 6 weeks, 3 months, 6 months and 1 year postoperative). | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores derived from standardized photographic assessment by two separate panels. The method used for assessment is based on methods described by Moolenburg and Strasser. Output parameter is a visual analogue score ranging from 0 (very poor facial volume) to 10 (excellent facial volume), and for skin quality 0 (pour skin quality) to 10 (excellent skin quality). Results of the patient questionnaire (FACE-Q) with the following endpoints, for example: number of complications, Return to work/Return to social activities and a patient evaluation of their own appearance using a visual analogue scale. This questionnaires will use the standardized FACE-Q list and will be completed during the following moments: preoperative, 6 weeks, 6 months, 12 months postoperative. Improvement in local skin parameters measured with the VISIA® Complexion Analysis (Canfield Scientific Inc.). Measurements will be done on a fixed mask for every subject on 4 separate moments in time: 6 weeks, 3 months, 6 months and 1 year post-operative in comparison to pre-operative measurements. | — |
Countries
Netherlands
Outcome results
None listed