Comparison of adhesion prevention capabilities of the modified starch powder-based medical devices 4DryField(®) PH, HaemoCer™ PLUS and StarSil(®) in the Optimized Peritoneal Adhesion Model

在优化的腹膜粘连模型中,比较了改性淀粉粉末基医疗器械 4DryField® PH、HaemoCer™ PLUS 和 StarSil® 的防粘连能力。

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Abstract

Background and Objectives: The rat Optimized Peritoneal Adhesion Model (OPAM) was developed to provoke adhesion formation with high reproducibility in incidence and extent. In a recent study, the starch-based hemostats 4DryField PH and Arista AH were tested for their capabilities to prevent adhesion formation, the former one certified for adhesion prevention and hemostasis, the latter one only certified for hemostasis. As two further starch-based hemostats, i.e., HaemoCer PLUS and StarSil, have officially been certified for adhesion prevention in the meantime, the present study was conducted to examine their efficacy. Materials and Methods: For this purpose, all three products were applied as a powder that was mixed in situ with saline solution to form a barrier gel. Adhesions were scored using the established macroscopically scoring systems by Lauder and Hoffmann, as well as histopathologically using the score by Zühlke. Animals receiving saline solution solely served as controls. Results: As previously published, 4DryField PH reduced peritoneal adhesions significantly. In contrast, HaemoCer PLUS and StarSil did not lead to a statistically significant reduction of adhesion formation. When comparing 4DryField PH, HaemoCer PLUS and StarSil, 4DryField PH was significantly more effective in preventing peritoneal adhesions. The results of the macroscopic investigation were confirmed by histopathological evaluations. Conclusions: Only 4DryField PH but neither HaemoCer PLUS nor StarSil were capable to effectively prevent adhesion formation, corroborating the assumption that starch-based hemostats do not generally have the capability to act as effective adhesion prevention devices.

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