Biocompatibility evaluation for the developed hydrogel wound dressing - ISO-10993-11 standards - in vitro and in vivo study

A V Thanusha; Veena Koul

doi:10.1088/2057-1976/ac3b2b

Biocompatibility evaluation for the developed hydrogel wound dressing - ISO-10993-11 standards - in vitro and in vivo study

Biomed Phys Eng Express. 2021 Nov 30;8(1). doi: 10.1088/2057-1976/ac3b2b.

Authors

A V Thanusha^{1

2}, Veena Koul^{1

2}

Affiliations

¹ Centre for Biomedical Engineering, Indian Institute of Technology Delhi, India.
² Biomedical Engineering Unit, All India Institute of Medical Sciences, New Delhi, India.

PMID: 34794128
DOI: 10.1088/2057-1976/ac3b2b

Abstract

Assessment of biocompatibility for the developed wound dressing plays a significant role in translational studies. In the present research work, a wound dressing has been developed using gelatin, hyaluronic acid and chondroitin sulfate using EDC as crosslinker in a specific manner. The characterized hydrogel wound dressing was evaluated for its biocompatibility studies by means of ISO-10993-11 medical device rules and standards. Various parameters like skin sensitization test, acute systemic toxic test, implantation study, intracutaneous reactivity test,in vitrocytotoxicity test and bacterial reverse mutation test, were evaluated and the results demonstrated its safety for the pre-clinical investigation.

Keywords: In vitro; In vivo studies; biocompatibility studies; gelatin; hydrogel; wound dressing.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Bandages*
Gelatin
Hyaluronic Acid
Hydrogels*

Substances

Hydrogels
Gelatin
Hyaluronic Acid