Hemostatic Efficacy and Safety of the Novel Medical Adhesive, MAR VIVO-107, in a Rabbit Liver Resection Model

Author:

Fukushima Kenji,Tanaka Hirokazu,Kadaba Srinivasan Pramod,Pawlowsky Kerstin,Kögel Babette,Uemoto Shinji,Ku Yonson,Tolba René H.

Abstract

Background: Topical hemostatic agents are useful when hepatic hemorrhage is difficult to control. The aim of this study was to evaluate the hemostatic efficacy and safety of a biodegradable polyurethane-based adhesive, MAR VIVO-107 (MAR), in comparison with a clinically used fibrin glue. Methods: Thirty female New Zealand white rabbits were randomly assigned to 3 study groups as follows: MAR (n = 10), fibrin glue (n = 10), and saline groups (n = 10). After standardized partial liver resection was performed, each agent was immediately applied to the wound area. Bleeding time until hemostasis and blood loss were recorded. After 7 days, body weight, hematology parameters, and serum levels of aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase were measured. Simultaneously, the severity of intra-abdominal adhesion was evaluated. Results: The mean bleeding time in the MAR (38 ± 10 s) and fibrin glue groups (65 ± 17 s) was significantly shorter than that in the saline group (186 ± 12 s). Similarly, the mean blood loss in the MAR (9 ± 3 g) and fibrin glue groups (9 ± 3 g) was significantly less than that in the saline group (23 ± 4 g). No significant differences in bleeding time and blood loss were found between the MAR and fibrin glue groups. The postoperative survival rate was 100% in all the groups. Body weight as well as hematological and serum biochemical values on day 7 were within the small and physiological range when compared with the preoperative baseline values, and significant differences were not detected among the MAR, fibrin glue, and saline groups. The severities of adhesion were similar between the 3 groups. Conclusion: Our data demonstrated that MAR was not inferior to fibrin glue in terms of hemostatic efficacy and safety.

Publisher

S. Karger AG

Subject

Surgery

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