CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Addition of PRP ( platelet rich plasma) to the lipograft +1 morebiological
Likely dose
Addition of PRP ( platelet rich plasma) to the lipograft 27 mlfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01461785
NCT01461785Phase 3Completed

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

Bergman Clinics·interventional·Posted Oct 28, 2011·Updated Oct 17, 2017

In Brief

A Phase 3 clinical trial evaluating Addition of PRP ( platelet rich plasma) to the lipograft and Lipofilling of the midface for Lipofilling and Human Autologous Fat Transfer. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
CollaboratorsZimmer Biomet

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2011
Enrollment StartApr 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.7 years ago

Interventions

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

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).