title: In vitro and in vivo biocompatibility evaluation of a polyalkylimide hydrogel for soft tissue augmentation.
abstract: Injectable fillers are commonly used in Plastic and Reconstructive Surgery to correct serious and slight aesthetic defects due to their low invasiveness and an easy implant technique procedure. Synthetic hydrogels are proposed as filler materials for their similarity with soft tissue and to avoid many disadvantages of naturally derived materials such as short persistence, allergenicity, and immunogenicity. Our studies are focused on the biocompatibility evaluation of a polyacrylic hydrogel containing alkylimide-amide groups and pyrogen free water (96%) (Bio-Alcamid by means of the in vitro cytotoxicity and mutagenicity assays and the in vivo skin irritation, sensitization test, and subcutaneous implant. All tests conducted on Bio-Alcamid showed no toxicity. It is a substance easy to inject and remove; it does not migrate, and its safety allows it to be a suitable filler for the correction of slight and also very serious aesthetic defects.
authors.affiliation: Polymekon Research, Cittadella della Ricerca, s.s.7, km 7+300, 72100 Brindisi, Italy. pierangela.ramires@polymekon.it
authors.forename: P A
authors.initials: PA
authors.lastname: Ramires
authors.forename: M A
authors.initials: MA
authors.lastname: Miccoli
authors.forename: E
authors.initials: E
authors.lastname: Panzarini
authors.forename: L
authors.initials: L
authors.lastname: Dini
authors.forename: C
authors.initials: C
authors.lastname: Protopapa
mesh_terms: D016475:3T3 Cells; D000180:Acrylic Resins / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology; D000818:Animals; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology*; D002470:Cell Survival; D006168:Guinea Pigs; D020100:Hydrogels / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology*; D020007:Implants, Experimental / Q000009:adverse effects / Q000382:microbiology / Q000592:standards; D008422:Materials Testing; D051379:Mice; D009152:Mutagenicity Tests; D010328:Patch Tests; D019736:Prostheses and Implants / Q000592:standards*; D011817:Rabbits; D019651:Plastic Surgery Procedures / Q000379:methods* / Q000592:standards
chemical_list: D000180:Acrylic Resins; C470344:Bio-Alcamid; D001672:Biocompatible Materials; D020100:Hydrogels