Stromal vascular fraction enriched lipofilling + PRP is believed to ameliorate current results in comparison to treating skin quality of the aging face by lipofilling+ PRP only.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Soft tissue augmentation by the means of lipofilling is nowadays a frequently
used technique in all forms of plastic surgery. In aesthetic facial surgery it
has shown to increase the rejuvenating effect, in reconstructive surgery it has
earned its place in the correction of soft tissue defects and athropy.
Post-operative loss of the transplanted fat remains an uncertain factor in the
procedure. In current literature, there are three main hypotheses on aetiology
of postoperative loss of transplanted adipocytes, resulting in decrease of the
grafted volume 1: reduced viability of the injected fat cells 2: impaired graft
revascularization at the target site 3: reduced ingrowth at the target site due
to fibrosis in the target area. Mentioned factors have limited the application
of (large) volume lipotransfer.
We have witnessed unexpected improvement of skin quality, similar positive
effects of lipofilling on skin quality have been reported by others. Coleman
observed softening of wrinkles, decreasing pore size and pigmentation
improvements on graft sites. Possible mechanisms of the claimed regenerative
properties of the lipograft are explained by the high number of Adipose Derived
Stem Cells. Because of the different names for Adipose Derived Stem Cells in
literature, we have decided to name these cells fat stem cells when we are
referring to Pericytes, Adipose Mesenchymal Stem Cells, Pre-Adipocytes, Adipose
Stromal Cells or Adipose Derived Stem cells. Although this phenomenon
frequently described in literature, no objective clinical results from
prospectively randomised studies have ever been performed up to today.
In this prospective study we investigate the potential beneficial effect of
adding stromal vascular fraction (with fat stem cells and small blood vessels)
to the state of the art treatment in facial plastic surgery (PRP +
lipofilling). Amelioration of skin quality improvement of the aging face is
anticipated. One group will receive lipofilling + PRP + stromval vascular
fraction and the other group will receive lipofiling + PRP + 0,9% NaCl
solution. Lipofilling and PRP have already proven their beneficial effect on
skin quality. They can be considered the golden standard in autologous
treatment of aging skin.
We are particularly interested in the stromal vascular fraction (with fat stem
cells and small blood vessels) injectables. Fat stem cells are regenerative
cells from adipose tissue, which can be easily isolated from lipoaspirate where
they probably are adjacent as pericytes to little blood vessels. It is well
known that fat stem cells can differentiate into ectodermal, endodermal and
mesenchymal differentiated cells. The possibility to differentiate into
vascular mural cells results in the promotion of angiogenesis and graft
survival. Most important role of fat stem cells is the conduction of the
adipose tissue turnover. Suctioned fat seems to lose a number of fat stem cells
during the liposuction and preparation phase compared to not suctioned fat. To
maximize the biological function and the differentiation capacity of
lipofilling, stromal vascular fraction is added. We developed a method to
dissociate stromal vascular fraction from lipoaspirate (by mechanical
dissociation of lipoaspirate without the addition of any enzymatic or chemical
substrates).
We trust the outcome of this study will ameliorate the current limitation of
lipofilling, especially large volume lipotransfer (allowing reconstruction in
one procedure instead of multiple with smaller volumes), and lipofilling in
pour vascularised tissue (eg. fibrosis after radiation therapy) by the addition
of stromal vascular fraction injectables. Furthermore, the suggested local skin
improvements could be used in scar revisions and burn treatment in the future,
bypassing invasive surgery.
Study objective
Stromal vascular fraction enriched lipofilling + PRP is believed to ameliorate
current results in comparison to treating skin quality of the aging face by
lipofilling+ PRP only.
Study design
Prospective double blind randomized controlled trial
Intervention
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 of the usual amount of harvested
fat will be harvested extra. Fat is centrifuged for 2,5 minutes at the maximum
speed of 3000 revolutions per minute after which the oil layer (top) and
serum/infiltrate layer (bottom) are drained away, preserving the middle stromal
vasculair fraction and the pellet. Fat injection is performed in 1-mm aliquots
with a short, curved Coleman cannula. 15 ml of fat is injected into the deep
subcutaneous plane of each side of the face, except for the lower lid/tear
trough region (where the injection is performed in the
supraperiosteal/submusclar plane) and the temporal area (where the level of
injection as above the superficial fascia of the temporal muscle).
All patients will receive lipofilling by the Coleman technique + the addition
of 2,5ml of PRP in each side of the face. Patients in group A will receive a
1ml injection of stromal vascular fraction in each side of the face and
patients in group B will receive a 1ml solution of 0,9% NaCl in each side of in
the face.
Study burden and risks
Of each included subject 55 ml of venous blood and 160 ml of lipoaspirate will
be drawn before the start of the operation. Subjects will already be under full
sedation anaesthesia at the time of the preparation and injection of fat stem
cell injectables or injection of 0,9% NaCl.
After a period of 6 weeks, 3 months, 6 months and 1 year, additional visits are
scheduled for the second, third, fourth and fifth measurements with the
Multi-probe system. In addition, the second, third, fourth and fifth
measurements with the VISIA® will be performed. Duration of each measuring
session is estimated at 35 minutes.
Potential risk of the included subject is low: PRP has been in use as an
adjuvant since 1985. No health risks or (serious) adverse events have been
reported to this date. PRP is currently used for several applications in
domestic and foreign hospitals. Stromal vascular fraction enriched lipofilling
has not ever increased health risks nor has showed to increase adverse events
of any kind to this date.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Females
- Aged 35-60
- Stable normal BMI (20-25) (1 year stable between 20-25)
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• Pregnancy or active child wish
• Frequent exposure to known carcinogenic substances (e.g. work related).
• Active or previous use of hormone replacement therapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54409.000.15 |
| OMON | NL-OMON20000 |