Abdominoplasty Clinical Trial
Official title:
Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in
plastic surgery. However, only pilot studies and retrospective uncontrolled trials have
reported the potential benefits of autologous glue treatment up to now. Therefore, a larger,
blinded, randomized and placebo-controlled clinical trial would be useful to determine
whether platelet-rich plasma is safe and effective in abdominoplasty procedures.
Currently, there are pharmacological options such as artificial fibrin glues composed of
homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk
of transmissible diseases and may induce allergic reactions. Therefore, autologous glues,
which are fully made of blood components from the patient itself (autologous fibrinogen
contained in PRP and autologous thrombin) represents a safe alternative to artificial
biological glues.
Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an
autologous activated thrombin serum, on the other hand, in a safe and rapid manner.
RegenKit®-Surgery is a CE-marked class IIb medical device.
This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared
with RegenKit®-Surgery when used in reconstructive abdominoplasty.
n/a
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