In vitro and In vivo Biocompatibility Evaluation of Freeze Dried Gelatin Haemostat

Abstract

Gelatin sponges developed by crosslinking gelatin with formaldehyde followed by controlled freeze-drying results in soft, spongy porous structures, which are useful in arresting bleeding during surgical procedures. The aim of this article is to conduct the in vivo evaluation of the gelatin sponge as per ISO 10993: Biological evaluation of medical devices; and prove its biocompatibility. The sponges were also evaluated by morphology analysis, tensile strength and blood-absorption studies. Sponges were found to be microporous with considerable mechanical strength to withstand any rupture during its application. Blood absorption studies showed good absorption behaviour. As per ISO 10993; cytotoxicity, skin irritation, sensitisation and blood compatibly studies has to be conducted to check the biocompatibility of a biomaterial. Gelatin sponge was found to be non-cytotoxic in Balb/c 3T3 cells. The experiments conducted on albino rabbits and guinea pig concluded that the material does not cause any irritation and sensitisation in vivo and is non-haemolytic when in contact with blood. Hence the material meets the requirements of a biocompatible haemostatic agent for the management of blood loss during surgical procedures.