Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model
Creators: name: Poehnert, Daniel
name: Abbas, Mahmoud
name: Maegel, Lavinia
name: Sambale, Franziska
name: Lavrentieva, Antonina
name: Kreipe, Hans-Heinrich
name: Klempnauer, Jürgen
name: Winny, Markus
Publisher: name: London : SAGE Publications Ltd.
Year: 2015
Subjects: subject: 4DryField® PH
subject: adhesion prevention agent
subject: biocompatibility
subject: cytotoxicity
subject: haemostatic agent
subject: polysaccharide
subject: rat model
subject: Adhesion
subject: Animals
subject: Biocompatibility
subject: Biomedical equipment
subject: Cell culture
subject: Cells
subject: Cytology
subject: Cytotoxicity
subject: Polysaccharides
subject: Tumors
subject: Abdominal injury
subject: Adhesion preventions
subject: Cytotoxic effects
subject: Foreign body reactions
subject: In-vitro testing
subject: Medical Devices
subject: Mononuclear cells
subject: Rat model
subject: Rats
subject: abdominal injury
subject: animal cell
subject: animal experiment
subject: animal model
subject: animal tissue
subject: Article
subject: cell growth
subject: cell viability
subject: controlled study
subject: degradation
subject: hemostasis
subject: histology
subject: human
subject: human cell
subject: in vitro study
subject: in vivo study
subject: laparotomy
subject: medical device
subject: mononuclear cell
subject: mouse
subject: nonhuman
subject: peritoneal injury
subject: priority journal
subject: rat
subject: tissue adhesion
subject: tumor cell line
subject: weight reduction
subject: Dewey Decimal Classification::600 | Technik::610 | Medizin, Gesundheit

description: 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.