To objectify improvements in local skin quality and graft take by the addition of PRP.
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 several skin measurement probes (Maxameter
mx18: Assessing melanin content and erythema level, Tewameter TM300: Skin
barrier function and transepidermal waterloss, Cutometer MPA580: Mechanical
parameters of the skin) on predetermined fixed positions in the face on
predetermined times .
Secondary outcome
Scores derived from standardized photographic assessment by two panels (
plastic surgeons and layperons). 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). Standardized photos will be
taken at the follow-up visits.
Results of the patient questionnaire with endpoints: number of complications,
Return to work/Return to social activities without masking in days. Patient
evaluation of their own appearance using a visual analogue scale ranging from 0
(very dissatisfied) to 10 (most satisfied).
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 volume of the transplanted fat remains an uncertain
factor in the procedure. In current literature, there are three main hypotheses
on etiology of postoperative decrease in the graft volume; 1: the viability of
the injected fat cells 2: impaired graft revascularization at the target site
3: the degree of fibrosis in the target area. Mentioned factors have limited
the application of (large) volume lipotransfer.
Positive effects of lipofilling on skin quality have been reported. 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. Although frequently described in literature, no objective results
have been published to this date.
In this prospective study we investigate new methods in preventing
postoperative volume loss by the addition of Platelet Rich Plasma (PRP),
derived from the patients own blood, to the injected fat graft. The added PRP
contains a wide range of growth factors for instance: Epidermal growth factor
(EGF), Platelet derived growth factor (PDGF-AA), Transforming growth factor
(TGF-B1, TGF-B2) ,Fibroblast growth factor (FGF) and Vascular endothelial
growth factor (VEGF).
All previously mentioned factors have shown to play a key role in tissue
regeneration after tissue damage. Especially VEGF is of great interest with the
ability to promote neo-angiogenesis in the graft, and thus, in theory, reducing
fat necrosis and seroma formation.
Current, scientifically validated, use of PRP include treatment of chronic and
soft tissue ulcerations, applications in the periodontal and oral surgery,
maxillofacial surgery, orthopaedic and trauma surgery, cosmetic and plastic
surgery, spinal surgery, heart bypass surgery, and burns. In all mentioned
applications, PRP showed to have a positive influence on the tissue recovery
and regeneration. Local PRP application in damaged animal and human skin
showed to have regenerative properties. Structural changes to the dermal layer
were observed in biopsies.
In this prospective, randomized clinical trial, lipofilling of the midface with
PRP is compared with lipofilling of the midface without PRP. The main objective
of this study is to investigate the effect of the addition of PRP to the
autologous fat transfer on local skin quality improvement, graft survival, and
recovery after the procedure.
The synergy achieved by lipofilling with PRP may hold many future applications
in both reconstructive and aesthetic plastic surgery. Current limitation of
lipofilling, especially large volume lipo transfer (allowing reconstruction in
one procedure in stead of multiple with smaller volumes) and lipofilling in
pour vascularised tissue (eg. fibrosis after radiation therapy) may be
countered by the addition of PRP. Furthermore, the suggested local skin
improvements could be used in scar revisions and burn treatment in the future,
bypassing invasive surgery.
Study objective
To objectify improvements in local skin quality and graft take by the addition
of PRP.
Study design
Randomized controlled trial, 16 vs 16 patients
Intervention
The Coleman technique for fat harvesting and injection is employed but refined
by utilizing a smaller, custom-made cannula for harvesting (inner diameter, 1.3
mm). The abdomen and upper legs are donor sites. Approximately two to three
times more fat is harvested than the estimated amount required for the
procedure. Fat is centrifuged for three 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 preadipocyte-rich pellet. Fat
injection is performed in 1-mm aliquots with a short, curved Coleman cannula.
Between 13 and 23 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/submuscular plane) and the
temporal area (where the level of injection was above the superficial fascia of
the temporal muscle).
Fat will be enriched with PRP in patients of group A.
Study burden and risks
Of each included subject 27 ml of venous blood will be drawn before the start
of the operation. Subjects will already be under general anaesthesia for the
main procedure during this process. During the regular 1 week post-operative
follow-up, the second measurements with the Multi-probe system will be
performed. After a period of 3 months and 1 year, additional visits are
scheduled for the third and fourth measurements. Duration of each measuring
session is estimated at 60 minutes.
PRP is used in several domestic and foreign hospitals for multiple applications
at time of this writing.
The measuring equipment used is a non-invasive and painless method of
objectifying skin quality.
Binckhorstlaan 149
Den Haag 2516 BA
NL
Binckhorstlaan 149
Den Haag 2516 BA
NL
Listed location countries
Age
Inclusion criteria
* Females
* Aged 45-65
* Stable normal BMI (20-25) (1 year stable between 20-25)
Exclusion criteria
* Male
* Aged below 45 or above 65 years
* Aged between 45 and 55 and in the menopause
* Aged between 55 and 65 and pre-menopause
* Prior operations in the mid-face
* Any oncological event in the patients history
* A known psychiatric condition
* A known systemic disease that will impair wound healing ( eg diabetus mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin).
* Smoking
* BMI <20 or >25 or an unstable BMI: 1 year ± 5 points.
- Pregnancy or active child wish
- Frequent exposure to known carcinogenic substances ( eg. work related).
* Active or previous use of hormone replacement therapy.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
---|---|
ClinicalTrials.gov | NCT01461785 |
CCMO | NL35142.098.11 |