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Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing

Tissue adhesives constitute a great possibility to improve conventional wound closure. In contrast to sutures, they enable nearly immediate hemostasis and can prevent fluid or air leaks. In the present study, a poly(ester)urethane-based adhesive was investigated which already proved to be suitable f...

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Autores principales: Bremer, Lisanne, Hagemeister, Kerstin, Moss, Michaela, Ernst, Lisa, Tolba, René H., Jockenhoevel, Stefan, Apel, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10058192/
https://www.ncbi.nlm.nih.gov/pubmed/36976092
http://dx.doi.org/10.3390/jfb14030168
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author Bremer, Lisanne
Hagemeister, Kerstin
Moss, Michaela
Ernst, Lisa
Tolba, René H.
Jockenhoevel, Stefan
Apel, Christian
author_facet Bremer, Lisanne
Hagemeister, Kerstin
Moss, Michaela
Ernst, Lisa
Tolba, René H.
Jockenhoevel, Stefan
Apel, Christian
author_sort Bremer, Lisanne
collection PubMed
description Tissue adhesives constitute a great possibility to improve conventional wound closure. In contrast to sutures, they enable nearly immediate hemostasis and can prevent fluid or air leaks. In the present study, a poly(ester)urethane-based adhesive was investigated which already proved to be suitable for different indications, such as reinforcing vascular anastomosis and sealing liver tissue. Using in vitro and in vivo setups, the degradation of the adhesives was monitored over a period of up to 2 years, to evaluate long-term biocompatibility and determine degradation kinetics. For the first time, the complete degradation of the adhesive was documented. In subcutaneous locations, tissue residues were found after 12 months and in intramuscular locations, tissue degradation was complete after about 6 months. A detailed histological evaluation of the local tissue reaction revealed good biocompatibility throughout the different degradation stages. After full degradation, complete remodeling to physiological tissue was observed at the implant locations. In addition, this study critically discusses common issues related to the assessment of biomaterial degradation kinetics in the context of medical device certification. This work highlighted the importance and encouraged the implementation of biologically relevant in vitro degradation models to replace animal studies or at least reduce the number of animals in preclinical testing prior to clinical studies. Moreover, the suitability of frequently used implantation studies based on ISO 10993-6 at standard locations was critically discussed, especially in light of the associated lack of reliable predictions for degradation kinetics at the clinically relevant site of implantation.
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spelling pubmed-100581922023-03-30 Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing Bremer, Lisanne Hagemeister, Kerstin Moss, Michaela Ernst, Lisa Tolba, René H. Jockenhoevel, Stefan Apel, Christian J Funct Biomater Article Tissue adhesives constitute a great possibility to improve conventional wound closure. In contrast to sutures, they enable nearly immediate hemostasis and can prevent fluid or air leaks. In the present study, a poly(ester)urethane-based adhesive was investigated which already proved to be suitable for different indications, such as reinforcing vascular anastomosis and sealing liver tissue. Using in vitro and in vivo setups, the degradation of the adhesives was monitored over a period of up to 2 years, to evaluate long-term biocompatibility and determine degradation kinetics. For the first time, the complete degradation of the adhesive was documented. In subcutaneous locations, tissue residues were found after 12 months and in intramuscular locations, tissue degradation was complete after about 6 months. A detailed histological evaluation of the local tissue reaction revealed good biocompatibility throughout the different degradation stages. After full degradation, complete remodeling to physiological tissue was observed at the implant locations. In addition, this study critically discusses common issues related to the assessment of biomaterial degradation kinetics in the context of medical device certification. This work highlighted the importance and encouraged the implementation of biologically relevant in vitro degradation models to replace animal studies or at least reduce the number of animals in preclinical testing prior to clinical studies. Moreover, the suitability of frequently used implantation studies based on ISO 10993-6 at standard locations was critically discussed, especially in light of the associated lack of reliable predictions for degradation kinetics at the clinically relevant site of implantation. MDPI 2023-03-21 /pmc/articles/PMC10058192/ /pubmed/36976092 http://dx.doi.org/10.3390/jfb14030168 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bremer, Lisanne
Hagemeister, Kerstin
Moss, Michaela
Ernst, Lisa
Tolba, René H.
Jockenhoevel, Stefan
Apel, Christian
Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title_full Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title_fullStr Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title_full_unstemmed Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title_short Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing
title_sort long-term degradation assessment of a polyurethane-based surgical adhesive—assessment and critical consideration of preclinical in vitro and in vivo testing
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10058192/
https://www.ncbi.nlm.nih.gov/pubmed/36976092
http://dx.doi.org/10.3390/jfb14030168
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