Registration Number
0223U001074,
0122U002158
, R & D reports
Title
Development, preclinical and clinical trials of autologous fibrin gel for use in surgery.
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Head
Korolova Dariya S., Кандидат біологічних наук
Registration Date
25-01-2023
Organization
Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine
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The possibility of using platelet rich blood plasma for the preparation of fibrin gel was demonstrated. A prototype kit for obtaining autologous fibrin gel was proposed, which contained a sterile syringe with a solution of enzyme activator of blood coagulation and calcium chloride and a vacuum system for blood collection containing sodium citrate, and the laboratory regulation for its production was developed. The goals and plan of clinical studies of the kit for the production of fibrin gel have been formed. A documents necessary for approval of clinical research was prepared and submitted to the State Service of Ukraine for Medicinal Products and Drug Control. The permission of the State Service of Ukraine on Medicines and Drugs Control to conduct clinical research was obtained and relevant clinical research was started. For the first time, the effectiveness of using a kit for obtaining fibrin gel to stimulate wound healing by primary tension in surgery was shown on flap anoplasty.
Product Description
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Hornytska Olha V.
Lugovska Nataliia Eduardivna
Platonova Tetiana M.
Chernyshenko Tamara Martynivna
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2023-01-25
