Correction: Safety and performance of surgical adhesives.

[This corrects the article DOI: 10.1371/journal.pone.0271531.].

Safety and Performance of Hemostatic Powders.

Background: Hemorrhage, a sudden and severe leakage of blood due to the disruption of blood vessels, is one of the most common causes of death from injuries worldwide. Severe bleeding accounts for more than 35% of pre-hospital deaths and about 40% of deaths recorded within 24 hours of injury. One of the methods for achieving homeostasis is the use of hemostatic powders. This study compares the basic safety and performance of the most popular hemostatic powders. Methods: Basic safety of commercially available products were evaluated using MTT, MEM elution assay, and endotoxin testing. The in vitro performance was evaluated using water absorption capacity, water absorption rate, and adhesion strength assays. Results: 4Seal, Starsil, and 4DryField extracts did not cause cytotoxicity in MTT and MEM elution assays. PerClot and SuperClot extracts demonstrated cytotoxic potential in MTT assay, while Arista extract was cytotoxic in both MEM elution and MTT assays. 4Seal has the lowest endotoxin contamination, followed by PerClot, 4DryField, SuperClot, Arista, and Starsil. 4Seal and Starsil showed significantly highest WAR among the tested samples, followed by 4DryField, Arista, PerClot, and SuperClot. Adhesion force is highest for 4Seal, followed by Starsil, PerClot, 4DryField Arista, and SuperClot. Conclusion: 4Seal is the most versatile in terms of safety and functional properties compared to 4DryField, Arista, PerClot, Starsil, and SuperClot.

Safety and performance of surgical adhesives.

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.

Biocompatibility of novel albumin-aldehyde surgical adhesive.

Many medical procedures could benefit from the use of tissue sealants which allow for reduced surgery time, limited blood loss, easier tissue handling, and fewer postoperative complications. The safety and biocompatibility of surgical sealants are of paramount importance therefore, the aim of this study is to investigate the biocompatibility of NE'X Glue Surgical Adhesive. Chemical characterization (VOC and elements), cytotoxicity (MEM elution), genotoxicity (AMES and MLA), endotoxin contamination, sensitization potential, intracutaneous reactivity, acute and subchronic systemic toxicity with implantation as well as pyrogenicity were evaluated to investigate the biocompatibility of the NE'X Glue Surgical Adhesive. Studies were conducted according to ISO 10993 standards. The biocompatibility requirements with accordance to ISO 10993-1 for NE'X Glue were met. In vitro studies showed that NE'X Glue surgical adhesive is non-cytotoxic and non-mutagenic. Also, in vivo studies demonstrated that NE'X Glue shows no signs of toxicity, has no pyrogenic potential, and is non-sensitizing and non-irritating. The chemical characterization showed that no compounds were identified above Analytical Evaluation Threshold (AET), and no elements with concentrations higher than element-specific PDE (µg/day) were detected. NE'X Glue Surgical Adhesive is a versatile and promising new surgical sealant with a wide range of potential applications and very good*0* biocompatibility.

Increased number of endothelial progenitor cells in the blood of patients with psoriasis vulgaris.

Introduction: Psoriasis vulgaris (PsV) is a common dermatosis characterized by excessive activation of neovascularization. Latest research has shown that endothelial progenitor cells (EPCs) are a crucial factor involved in the repair of endothelial injury and formation of new blood vessels, in a process termed postnatal vasculogenesis. However, the exact mechanism of creating psoriatic skin patches and the involvement of EPCs in this process remains unknown. Aim: To evaluate the number of EPCs in the blood of patients with PsV, characterized by the expression of specific cell surface markers, including CD45-, CD31+, CD34+ and CD133+. Material and methods: A total of 49 patients suffering from PsV and 40 healthy volunteers were enrolled in the study. The number of EPCs in each of the volunteers' whole blood samples was measured with a FACSCalibur flow cytometer using monoclonal antibodies directed against antigens specific for EPCs. Results: The number of EPCs was significantly higher in patients with psoriasis compared with the controls (p = 0.0007) and inversely correlated with disease severity assessed by PASI score (R = -0.2935, p = 0.0407). Statistical analysis did not show significant relations between the count of EPCs and age, body mass index, gender, disease duration, blood pressure, extent of itching, severity and frequency of pruritus, presence of bruises, vitamin D supplementation and smoking habit. Conclusions: The results of our studies indicate that patients with psoriasis showed an increased mobilization of EPCs compared with healthy individuals which correlated negatively with disease severity.