In the last years, several new methods have been developed in the field of biotechnology to obtain autologous cellular suspensions during surgery in order to provide one-step treatments for cutaneous loss of substances. To increase the rate of success in the treatment of skin lesions, the absence of extensive manipulation and the maintenance of sterile conditions are essential, in order to create a cellular suspension that can be immediately applied on the damaged area of the patients, thereby avoiding a longer processing in cleanrooms such as Cell Factories. Starting from small skin biopsies, grinding, centrifugation and other separation methods (e.g., enzymatic or mechanical), are frequently used to obtain a cellular suspension, which can be cultured in a growth medium. All of these methods generally require a long time of execution, stressing the cell structures, and leading to a reduction of cell viability. Another significant aspect is to obtain an autologous cellular suspension ready to be used by clinicians, for example, to repair damaged areas. Furthermore, it is well established that autologous tissue grafts survive the transfer procedures to eventually survive in the recipient site by the principles of induction and conduction. The ideal graft tissue should be readily available and have low antigenicity and donor site morbidity. Rigenera is a new method to obtain autologous micro-grafts starting from cutaneous tissues which were disaggregated by this protocol. Rigenera protocol is clinically based on the use of Rigeneracons (tissue disruptor) and the Rigenera Machine (tissue disruptor system). The tissue disruptor is a biological medical disruptor of human tissues able to disrupt small pieces of tissues using a grid provided by hexagonal blades and filtering cells and components of extracellular matrix with a cut-off of about 50 microns
L’obiettivo di questo studio è quello di valutare la guarigione di perdite di sostanza (PDS) ciutanea di medie dimensioni a diversa eziopatologia, utilizzando microinnesti di derma autologo, ottenuti con il sistema Rigenera, per implementare l’efficacia del sostituto dermico Integra, attualmente correntemente in uso presso l’Unità Operativa di chirurgia plastic come tecnica di preparazione del letto della ferita al successive auto-innesto dermo-epidermico (IDE) sottile, di regola prelevato in un secondo intervento chirurgico in sede cutanea sana con le stesse dimensioni dell’area lesionata. Attraverso l’applicazione dei micro-innesti dermici autologhi ci si propone come outcome primario di ridurre le dimensioni del successive prelievo di IDE e come outcome secondario di accelerare i processi di guarigione post-innesto e migliorare la qualità del tessuto ricostruito a distanza di 6 mesi: tutti gli outcome sono da valutare mediante comparazione con gli outcome ottenuti utilizzando il sostituto dermico Integra. Attraverso il trattamento ci si propone inoltre di migliorare la qualità della vita dei pazienti diminuendo il numero e la frequenza delle medicazioni nonce la somministrazione di anti-infiammatori e analgesic per via sistemica.
The use of autologous dermal micro-grafts to improve the efficacy of dermal substitutes in the treatment of soft-tissue loss: a monocentric, randomized, parallel-group controlled clinical trial
BASILICO, GIORGIA
2017/2018
Abstract
In the last years, several new methods have been developed in the field of biotechnology to obtain autologous cellular suspensions during surgery in order to provide one-step treatments for cutaneous loss of substances. To increase the rate of success in the treatment of skin lesions, the absence of extensive manipulation and the maintenance of sterile conditions are essential, in order to create a cellular suspension that can be immediately applied on the damaged area of the patients, thereby avoiding a longer processing in cleanrooms such as Cell Factories. Starting from small skin biopsies, grinding, centrifugation and other separation methods (e.g., enzymatic or mechanical), are frequently used to obtain a cellular suspension, which can be cultured in a growth medium. All of these methods generally require a long time of execution, stressing the cell structures, and leading to a reduction of cell viability. Another significant aspect is to obtain an autologous cellular suspension ready to be used by clinicians, for example, to repair damaged areas. Furthermore, it is well established that autologous tissue grafts survive the transfer procedures to eventually survive in the recipient site by the principles of induction and conduction. The ideal graft tissue should be readily available and have low antigenicity and donor site morbidity. Rigenera is a new method to obtain autologous micro-grafts starting from cutaneous tissues which were disaggregated by this protocol. Rigenera protocol is clinically based on the use of Rigeneracons (tissue disruptor) and the Rigenera Machine (tissue disruptor system). The tissue disruptor is a biological medical disruptor of human tissues able to disrupt small pieces of tissues using a grid provided by hexagonal blades and filtering cells and components of extracellular matrix with a cut-off of about 50 micronsÈ consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/25222