The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
NCT ID: NCT01461785
Last Updated: 2017-10-17
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2012-04-30
2015-01-31
Brief Summary
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Detailed Description
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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 the investigators examine 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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GROUP A: PRP +
Group A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma) with lipofilling
Addition of PRP ( platelet rich plasma) to the lipograft
27 ml blood will be drawn from the patient. The blood will be prepared according to the GPS System instructions (Biomet Biologics, LLC, Warsaw, Indiana USA). This desktop-size centrifuge has disposable cylinders to separate the different blood components (platelet rich plasma, PRP, platelet poor plasma, PPP, and red blood cells). The PRP is activated by adding calcium (15-volume % Ca2+ Sandoz®). creating activated Platelet Rich Plasma (aPRP).
The lipograft of Group A will be enriched with 3ml of autologous PRP
Lipofilling of the midface
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).
GROUP B: PRP -
Group B ( 16 subjects) will receive lipofilling without addition PRP. 27 ml blood will be drawn from the patient, but will be discarded, and not turned into PRP.
Lipofilling of the midface
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).
Interventions
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Addition of PRP ( platelet rich plasma) to the lipograft
27 ml blood will be drawn from the patient. The blood will be prepared according to the GPS System instructions (Biomet Biologics, LLC, Warsaw, Indiana USA). This desktop-size centrifuge has disposable cylinders to separate the different blood components (platelet rich plasma, PRP, platelet poor plasma, PPP, and red blood cells). The PRP is activated by adding calcium (15-volume % Ca2+ Sandoz®). creating activated Platelet Rich Plasma (aPRP).
The lipograft of Group A will be enriched with 3ml of autologous PRP
Lipofilling of the midface
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).
Eligibility Criteria
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Inclusion Criteria
* Aged 30-65
* Stable normal BMI (20-25) (1 year stable between 20-25)
Exclusion Criteria
* Aged below 30 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
* 20\<BMI\<25 or an unstable BMI: 1 year plus-minus 5 points.
* Pregnancy or active child wish
* Frequent exposure to known carcinogenic substances ( eg. work related).
* Active or previous use of hormone replacement therapy.
30 Years
65 Years
FEMALE
Yes
Sponsors
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Zimmer Biomet
INDUSTRY
Bergman Clinics
OTHER
Responsible Party
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JCN Willemsen, MD, PhD candidate
Principal investigator of clinical research
Principal Investigators
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Jeroen Stevens, MD, PhD
Role: STUDY_DIRECTOR
Bergman Clinics
Joep Willemsen, MD
Role: PRINCIPAL_INVESTIGATOR
Bergman Clinics
Locations
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Bergman Clinics
The Hague, South Holland, Netherlands
Countries
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References
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Other Identifiers
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JWJSLIPOFILLING
Identifier Type: -
Identifier Source: org_study_id