Background: As an effective alternative to conventional suture techniques, topical hemostatic
agents are widely used to control bleeding and close wounds in surgeries.
Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.