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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Bibliographic Details
Published in:	Journal of functional biomaterials Vol. 14; no. 3; p. 168
Main Authors:	Bremer, Lisanne, Hagemeister, Kerstin, Moss, Michaela, Ernst, Lisa, Tolba, René H, Jockenhoevel, Stefan, Apel, Christian
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 01-03-2023 MDPI
Subjects:	Adhesives Air leakage Analysis Anastomosis animal implantation model Animal models Aprotinin Biocompatibility biodegradable surgical sealant Biodegradation Biological products biomaterial degradation Biomaterials Biomedical materials Degradation Evaluation Hemostasis Hemostatics Implantation In vivo methods and tests Kinetics Laboratory animals long-term biocompatibility Medical equipment Medical technology Physiological apparatus Polyurethane polyurethane adhesive Polyurethane resins Surgical implants Tissues Transplants & implants Viscosity Wound healing Germany Aachen Germany United States > US biodegradable surgical sealant long-term biocompatibility animal implantation model polyurethane adhesive biomaterial degradation
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Current address: Haus für Experimentelle Therapie (HET), University Hospital Bonn, 53127 Bonn, Germany.
ISSN:	2079-4983 2079-4983
DOI:	10.3390/jfb14030168