Chitosan derivative-based hemostat: Irritation, hypersensitivity and absorbability study
AbstractThe objective of this study was to evaluate the safety of a carboxymethylchitosan-based hemostatic prototype for internal use, in terms of irritation, hypersensitivity and absorbability. Skin irritation and delayed-type hypersensitivity tests of the prototype in humans (n=30) were assessed by a patch test method. The human skin sites were graded and photographed after patch removal at each time point using a 4-point (0-3+) grading scale of increasing irritation related to ISO 10993-10:2002(E) and a 6-point grading scale of increasing allergy related to International Contact Dermatitis Research Group (ICDRG). The results demonstrated that the chitosan derivative-based hemostat did not cause skin irritation and delayed-type hypersensitivity on the tested humans’ skin. The absorbability of the hemostatic prototype was evaluated in the surgical treatment of penile paraffinoma in ten patients, which was conducted at Angthong Hospital, using a scrotal flap method. This method normally involved two surgical stages. In the first stage, two prototype specimens (2.5 cm x 2.5 cm x 0.20 cm) were implanted inside a patient’s treated area until the second operation was performed, normally in three months. The clinical results revealed that, after the whole treatment, no remaining specimens were physically observed. Furthermore, the histological results of the tissues where the specimens had been implanted showed no sample residues, indicating that the chitosan derivative-based hemostat was completely absorbed within three months.
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