The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Bergman Clinics.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by (Responsible Party):
JCN Willemsen, MD, PhD candidate, Bergman Clinics
ClinicalTrials.gov Identifier:
NCT01461785
First received: October 22, 2011
Last updated: July 14, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Lipofilling
Human Autologous Fat Transfer
Biological: Addition of PRP ( platelet rich plasma) to the lipograft
Procedure: Lipofilling of the midface
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer

Further study details as provided by Bergman Clinics:

Primary Outcome Measures:
  • Cutometry [ Time Frame: 1 year post-operative of the last included patient, estimate is 18 months ] [ Designated as safety issue: No ]
    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 . (pre-operative, 1 week postoperative, 3 months post-operative and 1 year post-operative.)


Secondary Outcome Measures:
  • Panel assessment [ Time Frame: 1 year post-operative of the last included patient, estimate is 18 months ] [ Designated as safety issue: No ]
    Standardized photos will be taken pre-, and post-operatively ( at 3 months and 1 year follow-up ) The photos will be analysed by two separate panels using validated scoring systems ( an adapted Moolenburg and Strasser). Both questionnaires will focus on changes in facial volume. The panels will consist of five independent plastic surgeons and five laypersons (all blinded).(pre-operative, 3 months post-operative and 1 year post-operative.)

  • Patient questionnaire [ Time Frame: 1 year post-operative of the last included patient, estimate is 18 months ] [ Designated as safety issue: No ]
    Analysis of a patient questionnaire sent at 4 weeks post-operative, with number of complications, recovery time (return to work/ return to social activity) and patient self-assessment (visual analogue score) as main endpoints. This questionnaire will use the standardized FACE-Q list that will be published in the fourth quarter of 2011. Use of topical skin products and sun exposure will be added to this questionnaire.


Estimated Enrollment: 32
Study Start Date: April 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP A: PRP +
Group A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma).
Biological: 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

Procedure: 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).
No Intervention: 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.
Procedure: 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).

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461785

Contacts
Contact: Jeroen Stevens, MD,PhD 0031-6-24810440 stevens.hp@gmail.com
Contact: Joep Willemsen, MD 0031-6-52384122 jcnwillemsen@gmail.com

Locations
Netherlands
Bergman Clinics Recruiting
The Hague, Zuid-holland, Netherlands, 2516 BA
Contact: Joep Willemsen, MD    0031-6-52384122    jcnwillemsen@gmail.com   
Principal Investigator: Joep Willemsen, MD         
Sponsors and Collaborators
Bergman Clinics
Biomet, Inc.
Investigators
Study Director: Jeroen Stevens, MD, PhD Bergman Clinics
Principal Investigator: Joep Willemsen, MD Bergman Clinics
  More Information

Publications:
Engebretsen L, Steffen K, Alsousou J, et al. IOC consensus paper on the use of platelet-rich plasma in sports medicine. Br J Sports Med 2010: 44: 1072-81.
Pusic AL, Klassen AF, Scott AM, Cano SJ. Discussion. The measure of face-lift patient satisfaction: the Owsley Facelift Satisfaction Survey with a long-term follow-up study. Plast Reconstr Surg 2010: 126: 258-60.

Responsible Party: JCN Willemsen, MD, PhD candidate, Principal investigator of clinical research, Bergman Clinics
ClinicalTrials.gov Identifier: NCT01461785     History of Changes
Other Study ID Numbers: JWJSLIPOFILLING
Study First Received: October 22, 2011
Last Updated: July 14, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bergman Clinics:
Platelet rich plasma
Dermal improvement
Graft survival

ClinicalTrials.gov processed this record on October 21, 2014