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

Research output: Contribution to journalArticleResearchpeer review

Authors

  • Daniel Poehnert
  • Mahmoud Abbas
  • Lavinia Maegel
  • Franziska Sambale
  • Antonina Lavrentieva
  • Hans Heinrich Kreipe
  • Jürgen Klempnauer
  • Markus Winny

Research Organisations

External Research Organisations

  • Hannover Medical School (MHH)
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Details

Original languageEnglish
Pages (from-to)463-471
Number of pages9
JournalJournal of Biomaterials Applications
Volume30
Issue number4
Publication statusPublished - 1 Oct 2015

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

ASJC Scopus subject areas

Cite this

Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model. / Poehnert, Daniel; Abbas, Mahmoud; Maegel, Lavinia et al.
In: Journal of Biomaterials Applications, Vol. 30, No. 4, 01.10.2015, p. 463-471.

Research output: Contribution to journalArticleResearchpeer review

Poehnert D, Abbas M, Maegel L, Sambale F, Lavrentieva A, Kreipe HH et al. Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model. Journal of Biomaterials Applications. 2015 Oct 1;30(4):463-471. doi: 10.1177/0885328215592257
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title = "Evaluation of the biological tolerability of the starch-based medical device 4DryField{\textregistered} PH in vitro and in vivo a rat model",
abstract = "Purpose To evaluate in vitro cytotoxicity/biocompatibility as well as in vivo tolerability of the novel polysaccharide 4DryField{\textregistered} 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{\textregistered} PH (PlantTec Medical GmbH). Using a rat model the impact of 4DryField{\textregistered} PH on animals viability and in vivo effects were macro- and micropathologically assessed. Results In vitro testing revealed no cytotoxic effect of 4DryField{\textregistered} PH nor enhancement of viability to tumour cell lines. In vivo viability of rats was unimpaired by 4DryField{\textregistered} PH. Bodyweight loss in animals with abdominal injury plus treatment with 4DryField{\textregistered} 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{\textregistered} 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{\textregistered} PH is not cytotoxic and does not enhance viability of tumour cell lines. High dose of 4DryField{\textregistered} PH of 1.09 g/kg bodyweight is well tolerated and reduces weight loss in animals with peritoneal injury. The biocompatibility of 4DryField{\textregistered} PH can be rated as being excellent.",
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T1 - Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model

AU - Poehnert, Daniel

AU - Abbas, Mahmoud

AU - Maegel, Lavinia

AU - Sambale, Franziska

AU - Lavrentieva, Antonina

AU - Kreipe, Hans Heinrich

AU - Klempnauer, Jürgen

AU - Winny, Markus

N1 - Publisher Copyright: © SAGE Publications. Copyright: Copyright 2017 Elsevier B.V., All rights reserved.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - 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.

AB - 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.

KW - 4DryField® PH

KW - adhesion prevention agent

KW - biocompatibility

KW - cytotoxicity

KW - haemostatic agent

KW - polysaccharide

KW - rat model

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DO - 10.1177/0885328215592257

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AN - SCOPUS:84948991922

VL - 30

SP - 463

EP - 471

JO - Journal of Biomaterials Applications

JF - Journal of Biomaterials Applications

SN - 0885-3282

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ER -

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