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

NCT01461785 | Completed Phase 2

• 1 other identifier: JWJSLIPOFILLING
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipofilling; Human Autologous Fat Transfer

Keywords

Platelet rich plasma; Dermal improvement; Graft survival

Outcome Measures

Primary Outcomes (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.)

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

Secondary Outcomes (2)

• Panel assessment

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

• Patient questionnaire

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

Study Arms (2)

GROUP A: PRP +

EXPERIMENTAL

Group A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma) with lipofilling

Biological: Addition of PRP ( platelet rich plasma) to the lipograft; Procedure: Lipofilling of the midface

GROUP B: PRP -

PLACEBO COMPARATOR

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

Interventions

Addition of PRP ( platelet rich plasma) to the lipograft BIOLOGICAL

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

GROUP A: PRP +

Lipofilling of the midface PROCEDURE

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 A: PRP +; GROUP B: PRP -

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• • 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
• \<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.

Sponsors & Collaborators

• Bergman Clinics: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Bergman Clinics

The Hague, South Holland, 2516 BA, Netherlands

Location

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Study Officials

• Jeroen Stevens, MD, PhD

  Bergman Clinics

  STUDY DIRECTOR

• Joep Willemsen, MD

  Bergman Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator of clinical research

Study Record Dates

• First Submitted: October 22, 2011
• First Posted: October 28, 2011
• Study Start: April 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 17, 2017

Record last verified: 2012-07

Locations

NL (1)