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. 2022 Aug 25;17(8):e0271531.
doi: 10.1371/journal.pone.0271531. eCollection 2022.

Safety and performance of surgical adhesives

Lukasz Szymanski  1   2 , Kamila Gołaszewska  2 , Justyna Małkowska  2 , Małgorzata Gołębiewska  2 , Judyta Kaczyńska  2 , Bartosz Gromadka  2 , Damian Matak  2
Affiliations

Safety and performance of surgical adhesives

Lukasz Szymanski et al. PLoS One. .

Erratum in

  • Correction: Safety and performance of surgical adhesives.
    Szymanski L, Gołaszewska K, Małkowska J, Gołębiewska M, Kaczyńska J, Gromadka B, Matak D. Szymanski L, et al. PLoS One. 2023 Nov 15;18(11):e0294614. doi: 10.1371/journal.pone.0294614. eCollection 2023. PLoS One. 2023. PMID: 37967064 Free PMC article.

Abstract

Background: Tissue adhesives are an alternative to conventional surgical sutures to reduce the time and cost of wound closure and to improve patient comfort. The use of tissue adhesives does not require any subsequent intervention and significantly lowers the volume and rate of blood loss, and reduces the need for transfusions during and after surgery. However, based on their formulation, tissue adhesives' safety profile and functional properties may differ. Therefore, this study aimed to evaluate the basic safety and performance of NE'X Glue® Surgical Sealant, BioGlue® Surgical Sealant, and PREVELEAKTM Surgical Sealant in vitro.

Methods: The basic safety of commercially available tissue adhesives was evaluated using MEM elution assay according to ISO 10993-5 and endotoxin level according to 85. USP. The in vitro performance was evaluated using lap-shear by tension loading test, burst strength test, degradation, and swelling assays.

Results: NE'X Glue®, BioGlue®, and PREVELEAKTM did not cause cytotoxicity in MEM elution assay. All surgical adhesives are below the general limit of endotoxin contamination of 20 EU/device. NE'X Glue® and BioGlue® showed the highest and comparable strength properties in lap shear and burst strength tests compared to PREVELEAKTM. NE'X Glue® and PREVELEAKTM are characterized by lower degradation potential than BioGlue®. PREVELEAKTM is characterized by the highest swelling when compared to NE'X Glue® and BioGlue®.

Conclusions: NE'X Glue® is most versatile in terms of functional properties while maintaining the same safety profile as BioGlue® and PREVELEAKTM.

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Conflict of interest statement

Dr. Damian Matak and Dr. Lukasz Szymanski have invented NE’X Glue®. All tests were per-formed in ISO 17025 accredited and GLP certified laboratory to ensure data integrity. Dr. Szymanski and Dr. Matak have no financial interests in NE’X Glue® Surgical Adhesive. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Images of cells after exposure to surgical adhesive extracts in the MEM elution study.
Fig 2
Fig 2. Results of ASTM F2255 strength properties of tissue adhesives in lap-shear by tension loading.
n = 10 and p < 0.05 was considered statistically significant.
Fig 3
Fig 3. Results of ASTM F2392 burst strength of surgical sealants.
n = 10 and p < 0.05 was considered statistically significant.
Fig 4
Fig 4. The degradation process of surgical sealants is illustrated as the absorbance spectra of water for injection after 1 week of incubation with the sample.
n = 3 and p < 0.05 was considered statistically significant.
Fig 5
Fig 5. Swelling presented as a weight gain [g] over time [weeks] of surgical sealants.
n = 3 and p < 0.05 was considered statistically significant.
Fig 6
Fig 6. Standard curve (R2 = 0,992).
Fig 7
Fig 7. Test system scheme.
Fig 8
Fig 8. System for testing strength properties of tissue adhesive.
Fig 9
Fig 9. Test system scheme.
See this image and copyright information in PMC

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  • Correction: Safety and performance of surgical adhesives.
    Szymanski L, Gołaszewska K, Małkowska J, Gołębiewska M, Kaczyńska J, Gromadka B, Matak D. Szymanski L, et al. PLoS One. 2023 Nov 15;18(11):e0294614. doi: 10.1371/journal.pone.0294614. eCollection 2023. PLoS One. 2023. PMID: 37967064 Free PMC article.

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