Abstract: | |
Purpose To evaluate in vitro cytotoxicity/biocompatibility as well as in vivo tolerability of the novel polysaccharide 4DryField® PH, certified for haemostasis and adhesion prevention. Methods In vitro cytotoxicity/viability testing according to ISO EN 10,993 using murine and human tumour cell lines incubated with 4DryField® PH (PlantTec Medical GmbH). Using a rat model the impact of 4DryField® PH on animals viability and in vivo effects were macro- and micropathologically assessed. Results In vitro testing revealed no cytotoxic effect of 4DryField® PH nor enhancement of viability to tumour cell lines. In vivo viability of rats was unimpaired by 4DryField® PH. Bodyweight loss in animals with abdominal injury plus treatment with 4DryField® PH was in the range of controls and less than in injured rats without treatment. At day 7 after surgery no formation of adhesions, neither macroscopic nor histological remnants nor signs of foreign body reaction were present in animals without injury. In animals with peritoneal injury and 4DryField® PH application, histopathological observation revealed minor residuals of polysaccharide in the depth of wound cavity embedded in a thickened subperitoneal layer; however, with a suggested intact neoperitoneum. The presence of mononuclear cells surrounding polysaccharide particles in varying states of degradation was observable as well. Conclusion 4DryField® PH is not cytotoxic and does not enhance viability of tumour cell lines. High dose of 4DryField® PH of 1.09 g/kg bodyweight is well tolerated and reduces weight loss in animals with peritoneal injury. The biocompatibility of 4DryField® PH can be rated as being excellent. © SAGE Publications.
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License of this version: | Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich. |
Publication type: | Article |
Publishing status: | publishedVersion |
Publication date: | 2015 |
Keywords english: | 4DryField® PH, adhesion prevention agent, biocompatibility, cytotoxicity, haemostatic agent, polysaccharide, rat model, Adhesion, Animals, Biocompatibility, Biomedical equipment, Cell culture, Cells, Cytology, Cytotoxicity, Polysaccharides, Tumors, Abdominal injury, Adhesion preventions, Cytotoxic effects, Foreign body reactions, In-vitro testing, Medical Devices, Mononuclear cells, Rat model, Rats, polysaccharide, abdominal injury, animal cell, animal experiment, animal model, animal tissue, Article, biocompatibility, cell growth, cell viability, controlled study, cytotoxicity, degradation, hemostasis, histology, human, human cell, in vitro study, in vivo study, laparotomy, medical device, mononuclear cell, mouse, nonhuman, peritoneal injury, priority journal, rat, tissue adhesion, tumor cell line, weight reduction |
DDC: | 610 | Medizin, Gesundheit |