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LipofillingPhase 2/3NCT01461785

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

A Phase 2/3 study testing Addition of PRP ( platelet rich plasma) to the lipograft and Lipofilling of the midface in people with Lipofilling and Human Autologous Fat Transfer, run by Bergman Clinics at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lipofilling, Human Autologous Fat Transfer
What is being tested?
Addition of PRP ( platelet rich plasma) to the lipograft and Lipofilling of the midface
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteNetherlands
Study dates
Apr 2012to Jan 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • •• 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Bergman Clinics

    The Hague, South Holland, 2516 BA

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Addition of PRP ( platelet rich plasma) to the lipograft, Lipofilling of the midface
Keywords
Platelet rich plasma, Dermal improvement, Graft survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Addition of PRP ( platelet rich plasma) to the lipograftBiological

    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 midfaceProcedure or surgery

    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).

Study groups in NCT01461785
Study groupRoleWhat they receive
GROUP A: PRP +ExperimentalGroup A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma) with lipofilling
Receives: Biological: Addition of PRP ( platelet rich plasma) to the lipograft; Procedure: Lipofilling of the midface
GROUP B: PRP -Placebo comparatorGroup 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.
Receives: Procedure: Lipofilling of the midface

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cutometry

    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.)

    Measured: 1 year post-operative of the last included patient, estimate is 18 months

Secondary outcomes (2)

  1. Panel assessment

    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.)

    Measured: 1 year post-operative of the last included patient, estimate is 18 months

  2. Patient questionnaire

    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.

    Measured: 1 year post-operative of the last included patient, estimate is 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461785
Sponsor's protocol ID
JWJSLIPOFILLING
Status last verified
Jul 2012
First submitted
22 Oct 2011
Last updated
17 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • Little JW. Applications of the classic dermal fat graft in primary and secondary facial rejuvenation. Plast Reconstr Surg. 2002 Feb;109(2):788-804. doi: 10.1097/00006534-200202000-00059.

    PubMed 11818872

  • Coleman SR. Facial recontouring with lipostructure. Clin Plast Surg. 1997 Apr;24(2):347-67.

    PubMed 9142473

  • Tzikas TL. Lipografting: autologous fat grafting for total facial rejuvenation. Facial Plast Surg. 2004 May;20(2):135-43. doi: 10.1055/s-2004-861754.

    PubMed 15643580

  • Clauser L, Polito J, Mandrioli S, Tieghi R, Denes SA, Galie M. Structural fat grafting in complex reconstructive surgery. J Craniofac Surg. 2008 Jan;19(1):187-91. doi: 10.1097/scs.0b013e31815c94f5.

    PubMed 18216687

  • Ducic Y, Pontius AT, Smith JE. Lipotransfer as an adjunct in head and neck reconstruction. Laryngoscope. 2003 Sep;113(9):1600-4. doi: 10.1097/00005537-200309000-00036.

    PubMed 12972941

  • Jackson IT, Simman R, Tholen R, DiNick VD. A successful long-term method of fat grafting: recontouring of a large subcutaneous postradiation thigh defect with autologous fat transplantation. Aesthetic Plast Surg. 2001 May-Jun;25(3):165-9. doi: 10.1007/s002660010115.

    PubMed 11426305

  • Conde-Green A, Baptista LS, de Amorin NF, de Oliveira ED, da Silva KR, Pedrosa Cda S, Borojevic R, Pitanguy I. Effects of centrifugation on cell composition and viability of aspirated adipose tissue processed for transplantation. Aesthet Surg J. 2010 Mar;30(2):249-55. doi: 10.1177/1090820X10369512.

    PubMed 20442104

  • Erdim M, Tezel E, Numanoglu A, Sav A. The effects of the size of liposuction cannula on adipocyte survival and the optimum temperature for fat graft storage: an experimental study. J Plast Reconstr Aesthet Surg. 2009 Sep;62(9):1210-4. doi: 10.1016/j.bjps.2008.03.016. Epub 2008 Jun 20.

    PubMed 18572007

  • Nguyen A, Pasyk KA, Bouvier TN, Hassett CA, Argenta LC. Comparative study of survival of autologous adipose tissue taken and transplanted by different techniques. Plast Reconstr Surg. 1990 Mar;85(3):378-86; discussion 387-9.

    PubMed 2304989

  • Nishimura T, Hashimoto H, Nakanishi I, Furukawa M. Microvascular angiogenesis and apoptosis in the survival of free fat grafts. Laryngoscope. 2000 Aug;110(8):1333-8. doi: 10.1097/00005537-200008000-00021.

    PubMed 10942136

  • Yamaguchi M, Matsumoto F, Bujo H, Shibasaki M, Takahashi K, Yoshimoto S, Ichinose M, Saito Y. Revascularization determines volume retention and gene expression by fat grafts in mice. Exp Biol Med (Maywood). 2005 Nov;230(10):742-8. doi: 10.1177/153537020523001007.

    PubMed 16246901

  • Sommer B, Sattler G. Current concepts of fat graft survival: histology of aspirated adipose tissue and review of the literature. Dermatol Surg. 2000 Dec;26(12):1159-66.

    PubMed 11134994

  • Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.

    PubMed 16936550

  • Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.

    PubMed 12475952

  • Nikolidakis D, Jansen JA. The biology of platelet-rich plasma and its application in oral surgery: literature review. Tissue Eng Part B Rev. 2008 Sep;14(3):249-58. doi: 10.1089/ten.teb.2008.0062.

    PubMed 18601587

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Addition of PRP ( platelet rich plasma) to the lipograft and Lipofilling of the midface in people with Lipofilling and Human Autologous Fat Transfer, run by Bergman Clinics at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cutometry (time frame: 1 year post-operative of the last included patient, estimate is 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461785, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.

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