Evaluating the Safety and Toxicity of a Modified Dextran-based Biopolymer as a Hemostat

Abstract

As an effective alternative to conventional suture techniques, topical hemostatic agents are widely used to control bleeding and close wounds in surgeries. This study was conducted to evaluate the efficacy and safety of a novel hydrogel hemostat that is easy to use in an applicator under normal conditions according to ISO 10993. The safety of DexGel, a natural surgical hemostat containing mainly dextran that is an effective hydrogel in bleeding stop, was evaluated and compared to that of AristaTM. APTT test and cytotoxicity tests (i.e., MTT assay, Crystal violet assay, and qualitative estimation) were carried out for considering safety in skin sensitization in a guinea pig model. This study has shown that DexGel does not cause any noticeable sensitization such as edema and erythema or observable toxicity for skin and does not disturb the coagulation process. In addition, cytotoxicity results approve its safety for cell survival. It can be concluded that the safety and efficacy of DexGel (5 g) are comparable or even better to that of AristaTM, which is a commercial and frequently used hemostat, and the lack of skin irritation and toxicity for DexGel alleviates initial safety concerns for products based on these polymers and oligomers.