Background: Hemostasis plays a crucial role during every surgery allowing for a bloodless operating field. Fast and effective surgery leads to a reduced risk of postoperative complications. One of the latest methods for achieving homeostasis is using natural polysaccharide-based hemostatic powders. The study aimed to evaluate the biocompatibility according to the ISO 10993 standards of 4SEAL® Hemostatic powder.
Methods: Chemical characterization (Headspace GC-MS, GC-MS, and ICP-MS), cytotoxicity, genotoxicity (MLA and AMES), endotoxin contamination, sensitization potential, intracutaneous reactivity, acute and subacute systemic toxicity with implantation, and pyrogenicity were evaluated to investigate the biocompatibility of the 4SEAL® Hemostatic powder. Studies were conducted according to ISO 10993 standards.
Results: The biocompatibility requirements according to ISO 10993-1 for 4SEAL® Hemostatic powder were met. Based on the conducted in-vitro studies, 4SEAL® Hemostatic powder shows a non-cytotoxicity and non-mutagenic potential. Also, the results of in vivo studies of 4SEAL® Hemostatic powder shows no signs of toxicity, non-sensitizing, non-irritating, and no pyrogenicity potential. In the chemical characterization of 4Seal® Hemostatic Powder, no compounds were identified above Analytical Evaluation Threshold (AET) and no elements with concentrations higher than element-specific PDE [μg/day] were detected.
Conclusions: 4SEAL® Hemostatic powder is a promising new hemostatic agent with a wide range of potential applications and excellent biocompatibility.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8981750 | PMC |
| http://dx.doi.org/10.1186/s40824-022-00258-6 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Double Cross-linked Methacrylated Carboxymethyl Pea Starch Cryogels with Highly Compressive Elasticity and Hemostatic Function.
Biomacromolecules
January 2025
Department of Mechanical Engineering, University of Manitoba, Winnipeg, MB R3T 2N2, Canada.
As an abundant renewable natural material, starch has attracted unprecedented interest in the biomedical field. Carboxylated starch particles have been investigated for topical hemostasis, but the powder may not provide physical protection or support for wounds. Here, we prepared macroporous cryogel sponges of methacrylated carboxymethyl starch (CM-ST-MA) containing a covalent and a calcium ionic double network.
View Article and Find Full Text PDFHistology Assessment of Chitosan-Polyvinyl Alcohol Scaffolds Incorporated with CaO Nanoparticles.
Molecules
January 2025
Grupo Biomateriales Dentales, Escuela de Odontología, Universidad del Valle, Calle 4B # 36-00, Cali 760001, Colombia.
Scaffolds for regenerative therapy can be made from natural or synthetic polymers, each offering distinct benefits. Natural biopolymers like chitosan (CS) are biocompatible and biodegradable, supporting cell interactions, but lack mechanical strength. Synthetic polymers like polyvinyl alcohol (PVA) provide superior mechanical strength and cost efficiency but are not biodegradable or supportive of cell adhesion.
View Article and Find Full Text PDFRole of Absorbable Polysaccharide Hemostatic Powder in the Prevention of Complications After Axillary Lymph Node Dissection in Breast Cancer Patients: A Multicenter Retrospective Analysis.
Medicina (Kaunas)
January 2025
Department of Advanced Since and Surgery, General, Mini-Invasive, Oncological and Obesity Surgery, Luigi Vanvitelli University of Campania, 80138 Naples, Italy.
: Although breast surgery has undergone a drastic de-escalation in recent decades, axillary dissection is still indicated in some selected cases. Unfortunately, in 3-85% of cases, complications such as seroma formation occur, highlighting the need for more accurate hemostasis systems. The aim of this study is to evaluate the effectiveness of absorbable polysaccharide hemostatic such as Haemocer in preventing postoperative seroma.
View Article and Find Full Text PDFA self-gelling hemostatic powder boosting radiotherapy-elicited NK cell immunity to combat postoperative hepatocellular carcinoma relapse.
Biomaterials
December 2024
Department of Hepatic Surgery and Liver Transplantation Center, The Third Affiliated Hospital of Sun Yat-sen University, Organ Transplantation Institute, Sun Yat-sen University, Organ Transplantation Research Center of Guangdong Province, Guangdong Province Engineering Laboratory for Transplantation Medicine, Guangzhou, 510630, China; Biotherapy Centre & Cell-gene Therapy Translational Medicine Research Centre, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510630, China. Electronic address:
Liver resection represents a main curative treatment for patients with early-stage hepatocellular carcinoma (HCC), but there is a rather high incidence of postoperative HCC relapse, which severely shortens long-term survival time. Currently, no standard adjuvant strategies are available for preventing HCC relapse in clinical practice. Impaired natural killer (NK) cell anti-tumor immunity has been disclosed as a crucial root of HCC relapse, indicating that reinstating NK cell anti-tumor immunity may show promise to curb HCC relapse.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!