title: Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of General, Abdominal and Transplantation Surgery, Hannover Medical School, Germany poehnert.daniel@mh-hannover.de.
authors.forename: Daniel
authors.initials: D
authors.lastname: Poehnert
authors.affiliation: Department of Pathology, Hannover Medical School, Germany.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Abbas
authors.affiliation: Department of Pathology, Hannover Medical School, Germany.
authors.forename: Lavinia
authors.initials: L
authors.lastname: Maegel
authors.affiliation: Institute of Technical Chemistry, Leibniz University Hannover, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Sambale
authors.affiliation: Institute of Technical Chemistry, Leibniz University Hannover, Germany.
authors.forename: Antonina
authors.initials: A
authors.lastname: Lavrentieva
authors.affiliation: Department of Pathology, Hannover Medical School, Germany.
authors.forename: Hans-Heinrich
authors.initials: HH
authors.lastname: Kreipe
authors.affiliation: Department of General, Abdominal and Transplantation Surgery, Hannover Medical School, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Klempnauer
authors.affiliation: Department of General, Abdominal and Transplantation Surgery, Hannover Medical School, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Winny
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry / Q000633:toxicity*; D045744:Cell Line, Tumor; D006490:Hemostatics / Q000737:chemistry / Q000633:toxicity*; D006801:Humans; D008297:Male; D008422:Materials Testing; D010537:Peritoneum / Q000187:drug effects / Q000293:injuries*; D051381:Rats; D011917:Rats, Inbred Lew; D013213:Starch / Q000031:analogs & derivatives / Q000633:toxicity*
chemical_list: D001672:Biocompatible Materials; D006490:Hemostatics; D013213:Starch
keywords: 4DryField® PH; adhesion prevention agent; biocompatibility; cytotoxicity; haemostatic agent; polysaccharide; rat model