Abstract
The aim of the present study was to evaluate local irritant effects to rabbit skin following a single application of test samples of non-sterile polyamide non-absorbable surgical sutures POLYMED®. The polar and nonpolar extracts were prepared by using saline solution and olive oil, respectively, after sinking the materials tested (2.0 g) in 10 ml of the corresponding liquid. Incubation was carried out at the temperature of 37 °C for 72 h. The saline solution and pure olive oil, which had no contact with the materials tested, were used as negative control samples and were incubated under the same conditions as above. 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 the extract tested and 5 injections of the control solution, each of 0.2 ml, were carried out. The degree of irritation was scored at 4, 24, 48, 72 hours after injection and no skin changes were found. The intracutaneous irritation index (III) was calculated and yielded 0.0. Hence it was concluded that under the experimental conditions the extracts of the material tested, i.e. non-sterile polyamide non-absorbable surgical sutures POLYMED®, were ‘non-irritant’ to the skin of rabbits when compared with the respective control groups. The experimental procedure was conducted according to ISO10993-10.
Highlights
POLYMED® are non-sterile, synthetic, woven multifilament surgical sutures made of Polyamide 6/6 (Medica webpage - http://fw.medica.bg/en/home.html?products/surgicals.html)
The aim of the present study was to evaluate local irritant effects to rabbit skin following a single application of test samples of non-sterile polyamide non-absorbable surgical sutures POLYMED®
The polar and nonpolar extracts were prepared by using saline solution and olive oil, respectively, after sinking the materials tested (2.0 g) in 10 ml of the corresponding liquid
Summary
POLYMED® are non-sterile, synthetic, woven multifilament surgical sutures made of Polyamide 6/6 Surgical suture needs to be evaluated in terms of the possibility to cause irritation reaction or toxic response. To minimize any potential hazards to the patients, it is essential that biocompatibility assessments be conducted for all materials that are used in medical devices. Multiple tests may be needed to determine the biocompatibility of the material. The ISO intracutaneous reactivity test is the standard protocol for determining a medical device‘s potential for causing irritation. Intracutaneous (intradermal) reactivity tests determine the localized reaction of tissue to extracts of medical devices, biomaterials, or prostheses in the final product form. Because these tests focus on determining the biological response of leachable agents that may be present in biomaterials, their extracts in various solvents are utilized to prepare the injection solutions.
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