Clinical trial NCT01461785: The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
Official title: The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lipofilling
Human Autologous Fat Transfer
Keywords: Platelet rich plasma
Dermal improvement
Graft survival
Lead sponsor: Bergman Clinics
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2011-10-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Females
* Aged 30-65
* Stable normal BMI (20-25) (1 year stable between 20-25)

Exclusion Criteria:

•• Male

* 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.

Primary outcomes:
measure: Cutometry
timeFrame: 1 year post-operative of the last included patient, estimate is 18 months
Secondary outcomes:
measure: Panel assessment
timeFrame: 1 year post-operative of the last included patient, estimate is 18 months
measure: Patient questionnaire
timeFrame: 1 year post-operative of the last included patient, estimate is 18 months
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Bergman Clinics
state: Zuid-holland
Study officials:
affiliation: Bergman Clinics
name: Jeroen Stevens, MD, PhD
role: STUDY_DIRECTOR
affiliation: Bergman Clinics
name: Joep Willemsen, MD
role: PRINCIPAL_INVESTIGATOR
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