The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
Condition: Lipofilling; Human Autologous Fat Transfer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich
      Plasma (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.
    

Detailed description: 
      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 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.
    

Intervention name(s): Addition of PRP ( platelet rich plasma) to the lipograft; Lipofilling of the midface
Intervention type(s): Biological; Procedure
Intervention description(s): 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; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Platelet rich plasma; Dermal improvement; Graft survival