Immunological safety evaluation of a horse collagen haemostatic pad.

The safety of a haemostatic and wound dressing collagen pad (Antema®) obtained from horse Achilles tendon treated with pepsin, has been studied from the immunological point of view. A sensitizing activity test and maximization test in guinea pig has been performed and its capacity of inducing antibodies has been tested in rabbit and man. In guinea pig the collagen pad tested did not show any symptom of allergic reaction, in rabbit it induced a weak immunological response, without any clinical symptoms, detectable with the ELISA method only at very high serum concentration levels (1 : 20). In a clinical trial, 20 patients submitted to different types of surgery in which the product had been used as haemostatic pad and left in the surgery area until absorption, did not develop any immunological clinical reaction. One year after the operation no traces of anti-collagen antibodies have been found with the ELISA method in the sera of those patients.