Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model. (October 2015)

• Record Type: Journal Article
• Authors: Poehnert, Daniel; Abbas, Mahmoud; Maegel, Lavinia; Sambale, Franziska; Lavrentieva, Antonina; Kreipe, Hans-Heinrich; Klempnauer, Jürgen; Winny, Markus
• Is Part Of: Journal of biomaterials applications. Volume 30:Number 4(2015:Nov.)
• Page Start: 463
• Page End: 471
• Publication Date: 2015-10
• Subjects: 4DryField® PH -- polysaccharide -- haemostatic agent -- adhesion prevention agent -- biocompatibility -- cytotoxicity -- rat model; Biomedical engineering -- Periodicals; Biomedical materials -- Periodicals; 610.28
• DOI: 10.1177/0885328215592257
• Languages: English
• ISSNs: 0885-3282

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.