In vitro and in vivo study of the biocompatibility and adjacent soft tissue response to synthetic polyvinyl formal hydrogel implant

Authors

  • Yu. M. Samchenko F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • S. M. Dybkova F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • A.P. Maletskyi SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine" https://orcid.org/0000-0002-7135-5218
  • L. O. Kernosenko F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • O.V. Artiomov SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine"
  • T. G. Gruzina F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • L. S. Reznichenko F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • T. P. Poltoratska F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • N. O. Pasmurtseva F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • N. M. Zholobak D.K. Zabolotny Institute of Microbiology and Virology, NAS of Ukraine
  • V. I. Podolska F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • I. Ie. Mamyshev Institute of Geological Science, NAS of Ukraine
  • I. I. Volobaiev F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA
  • N. M. Bigun Lviv Regional Clinical Hospital

DOI:

https://doi.org/10.31288/oftalmolzh202434551

Keywords:

hydrogels, orbit, orbital and periorbital area, biocompatibility, implantation

Abstract

Background: Given a rising tendency in the rate of ocular trauma, there is an increasing need in surgeries for orbital, ocular adnexal and periorbital reconstruction. The susceptibility to resorption is a common drawback of the biological tissues used as a plastic material in contemporary orbital surgery. Non-biological hollow porous polyvinyl formal (PVF) hydrogel implants capable of integration with adjacent biological tissues offer a new opportunity for reconstructive surgery.

Purpose: To examine the in vivo and in vitro biocompatibility of a synthetic PVF-based hydrogel implant material.

Material and Methods: Scanning electron microscopy (SEM) analysis; in vitro evaluation of the biocompatibility  of the PVF hydrogel implant material in terms of its cytotoxicity, genotoxicity and effects on marker enzymatic activities of L929 fibroblasts; and in vitro study on implant incorporation.

Results: A cross-linked polyvinyl formal hydrogel for orbital endoprosthesis surgery was synthesized. Our in vitro cytotoxicity and genotoxicity tests of the hydrogel and tests of its effects on marker enzymatic activities of L929 fibroblasts demonstrated safety. All hydrogel implant samples, after being sealed into polypropylene bags and autoclaved for 15 min at 121 °C and 1.04 atm steam pressure, were found to be sterile. In all rats in which the hybrid hydrogel implant was placed subcutaneously in the back, there was prompt relief of edema at the site of postoperative suture. The inflammatory reactions seen in the tissues adjacent to the implant included mostly mild diffuse lymphocytic infiltration close to the implant surface, with no inflammatory reactions seen at the sites more remote from the implant.

Conclusion: Our in vivo and in vitro study of the PVF hydrogel demonstrated its high biocompatibility in terms of its cytotoxicity, genotoxicity and effects on marker enzymatic activities of fibroblast cells, with no post-implantation complications, but a step-by-step improvement in the relationship between the implant and adjacent tissues. The findings of this study allow us to recommend the developed PVF hydrogel for further research on the potential for using it as an implant for filling postoperative cavities and endoprosthesis in orbital and periorbital reconstruction.

Author Biographies

Yu. M. Samchenko, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Dr Sc (Chem) and Department Chief, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

S. M. Dybkova, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Cand Sc (Biol), Senior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

A.P. Maletskyi, SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine"

Dr Sc (Med.), Prof. and Department Chief, SI “The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine”, Odesa, Ukraine

L. O. Kernosenko, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Cand Sc (Chem), Senior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

O.V. Artiomov, SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine"

Cand Sc (Med) and Laboratory Chief, SI “The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine”, Odesa, Ukraine

T. G. Gruzina, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Cand Sc (Biol), Senior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

L. S. Reznichenko, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Senior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

T. P. Poltoratska, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Chief Research Engineer, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

N. O. Pasmurtseva, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Junior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

N. M. Zholobak, D.K. Zabolotny Institute of Microbiology and Virology, NAS of Ukraine

Cand Sc (Biol), Senior Researcher, Zabolotny Institute of Microbiology and Virology, NAS of Ukraine

V. I. Podolska, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Senior Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

I. Ie. Mamyshev, Institute of Geological Science, NAS of Ukraine

Researcher, Institute of Geological Science, NAS of Ukraine, Kyiv, Ukraine

I. I. Volobaiev, F.D. Ovcharenko Institute of biocolloidal chemistry of Ukrainian National Academy of Scienses: Kyiv, UA

Cand Sc (Chem), Researcher, F.D. Ovcharenko Institute of Biocolloidal Chemistry, NAS of Ukraine, Kyiv, Ukraine

N. M. Bigun, Lviv Regional Clinical Hospital

Cand Sc (Med), Lviv Regional Clinical Hospital, Lviv, Ukraine

References

Tselomudriy AI, Venger GE, Rizvaniuk AV, Pohoreliy DN, Putienko VA. [Peculiarities of surgical rehabilitation of soldiers with battle eye wounds in modern conditions]. In: [Abstracts of the scientific and practical conference with international participation «Filatov Memorial Lectures 2016», dedicated to the 80th anniversary of the Filatov Institute of Eye Diseases and Tissue Therapy of NAMS of Ukraine and 14th Black Sea Ophthalmological Congress]. 19-20 May 2016; Odessa, Ukraine; p. 95. Ukrainian.

Uvarova IV, Maksymenko VB. [Bio‐compatible Materials for Medical Products. Educational Manual. Biomedical Engineering Department. National Technical University of Ukraine "KPI")]. Kyiv: KIM, 2013. Ukrainian.

Phillips TJ. Cultured epidermal allograft - a permanent or temporary solution? Transplantation. 1991 May;51(5):937-41. https://doi.org/10.1097/00007890-199105000-00001

Samchenko YuM, Dybkova SM, Maletskyy AP, Kernosenko LO, Gruzina TG, Pasmurtseva NO, et al. Antimicrobial effects of hydrogel implants incorporating gold nanoparticles and albucide and developed for reconstructive surgery in the orbit and periorbital area. Journal of Ophthalmology (Ukraine). 2023; 5(514):27-33. https://doi.org/10.31288/oftalmolzh202352733

Samchenko YuM, Maletskiy AP, Bigun NM, Dolynskyy GA, Kernosenko LO, Pasmurtseva NO, et al. Dynamics of depositing and diffusion of drugs (chlorhexidine, 5-fluorouracil and doxorubicin) in hydrogel implants with different hydrogel crosslinking densities. Journal of Ophthalmology (Ukraine). 2020;3:53-60. https://doi.org/10.31288/oftalmolzh202035360

Maletskyy A, Samchenko Yu, Bigun N. Improving the Antitumor Effect of Doxorubicin in the Treatment of Eyeball and Orbital Tumors. In: Hilal Arnouk, Bassam Hassan, editors. Advances in Precision Medicine Oncology. London: IntechOpen; 2021. https://doi.org/10.5772/intechopen.95080

Biological evaluation of medical devices. Part 12: Sample preparation and reference materials. Fourth edition 2012-07-01. Reference number ISO 10993-12:2012(E) - 28 р. 2. International Standard ISO 10993-1, «Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process» - June 16, 2016.

Methods in Molecular Biology. In Situ Detection of DNA Damage. Methods and protocols. Ed. by Vladimir V. Didenko. 2002; 203:299.

Lowry OH, Rosenbrough NJ, Farr AL. Protein measurement with the Folin phenol reagent. J Biol Chem. 1951;193:265-275. https://doi.org/10.1016/S0021-9258(19)52451-6

Prokhorova MI, editor. [Methods of biochemical research: Lipid and energy metabolism]. Leningrad: LGU Publishing House; 1982. Russian.

Varbanets LD, Zdorovenko GM, Knirel YuM. [Methods of endotoxin research]. Kyiv: Naukova Dumka; 2006. Russian.

[On the approval of the "Technical regulation on active implantable medical products": Order № 755 of the Cabinet of Ministers of Ukraine of 2 October, 2013, as amended on 30 November, 2022]. Ukrainian. Available at: https://zakon.rada.gov.ua/laws/show/755-2013-%D0%BF#Text

Published

2024-07-02

How to Cite

1.
Samchenko YM, Dybkova SM, Maletskyi A, Kernosenko LO, Artiomov O, Gruzina TG, Reznichenko LS, Poltoratska TP, Pasmurtseva NO, Zholobak NM, Podolska VI, Mamyshev II, Volobaiev II, Bigun NM. In vitro and in vivo study of the biocompatibility and adjacent soft tissue response to synthetic polyvinyl formal hydrogel implant. J.ophthalmol. (Ukraine) [Internet]. 2024 Jul. 2 [cited 2024 Jul. 3];(3):45-51. Available from: https://ua.ozhurnal.com/index.php/files/article/view/138

Issue

Section

Experimental Studies