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

J Biomater Appl. 2015 Oct;30(4):463-71. doi: 10.1177/0885328215592257. Epub 2015 Jun 26.

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.

Keywords: 4DryField® PH; adhesion prevention agent; biocompatibility; cytotoxicity; haemostatic agent; polysaccharide; rat model.

MeSH terms

  • Animals
  • Biocompatible Materials / chemistry
  • Biocompatible Materials / toxicity*
  • Cell Line, Tumor
  • Hemostatics / chemistry
  • Hemostatics / toxicity*
  • Humans
  • Male
  • Materials Testing
  • Peritoneum / drug effects
  • Peritoneum / injuries*
  • Rats
  • Rats, Inbred Lew
  • Starch / analogs & derivatives
  • Starch / toxicity*

Substances

  • Biocompatible Materials
  • Hemostatics
  • Starch