Abstract

STERIMED^®ALGOis a sterile non-sticking dressing for wounds of different origin. As a medical device it should be evaluated for biocompatibility. To determine the potential of STERIMED^®ALGOto produce irritation from a single intracutaneous application to the skin of New Zealand rabbits. The test article of this dressing was extracted in 0,9 % sodium chloride and in pure Olive oil. These extracts were evaluated for intracutaneous reactivity based on the requirements of the International Organization for Standardization 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Delayed Type Hypersensitivity. The assessments of the extracts from each material were conducted on 2 albino rabbits of the New Zealand breed. On the back of each animal 5 intracutaneous injections of tested extract and 5 injections of control solution, each of 0.2 ml, were carried out. Observations for erythema and edema were conducted at 4, 24, 48, 72 hours after injection and no skin changes were found.  The intracutaneous irritation index (III) was calculated and came as 0.00. Based on the results, it was concluded that under the experimental conditions the extracts of the tested material sterile non-sticking dressing STERIMED^®ALGOwas ‘non-irritant’ to the skin of rabbits when compared with the respective control groups.