Hemorrhagic shock is the primary cause of death in patients with severe trauma, and the development of rapid and efficient hemostatic methods is of great significance in saving the lives of trauma patients. In this study, a polycaprolactone (PCL) nanofiber membrane was prepared by electrospinning. A PCL–PDA loading system was developed by modifying the surface of polydopamine (PDA), using inspiration from mussel adhesion protein, and the efficient and stable loading of thrombin (TB) was realized to ensure the bioactivity of TB. The new thrombin loading system overcomes the disadvantages of harsh storage conditions, poor strength, and ease of falling off, and it can use thrombin to start a rapid coagulation cascade reaction, which has the characteristics of fast hemostasis, good biocompatibility, high safety, and a wide range of hemostasis. The physicochemical properties and biocompatibility of the PCL–PDA–TB membrane were verified by scanning electron microscopy, the cell proliferation test, the cell adhesion test, and the extract cytotoxicity test. Red blood cell adhesion, platelet adhesion, dynamic coagulation time, and animal models all verified the coagulation effect of the PCL–PDA–TB membrane. Therefore, the PCL–PDA–TB membrane has great potential in wound hemostasis applications, and should be widely used in various traumatic hemostatic scenarios.
Tetanus remains an important global public health concern. Currently, the only recommended passive immunization therapy for tetanus prophylaxis is plasma-derived human tetanus immunoglobulin (HTIG), which faces a global supply shortage and can transmit infectious pathogens. Despite not being endorsed by WHO due to safety concerns, equine tetanus antitoxin remains widely used in some countries. We conducted a randomized, double-blind, phase 3 trial to evaluate siltartoxatug—a first-in-class recombinant monoclonal antibody—for tetanus postexposure prophylaxis. Participants (n = 675) were randomized (2:1) to receive a single intramuscular injection of siltartoxatug 10 mg or HTIG 250 IU. The study met its primary outcome, with siltartoxatug demonstrating superiority to HTIG in the proportion of participants with an increase of anti-tetanus neutralizing antibody titers from baseline (ΔTiter) ≥ 0.01 IU ml−1 (95.4% versus 53.2%; intergroup difference 42.3% (95% confidence interval, 35.5–49.1; P < 0.0001)). The safety profiles were comparable, with similar incidence of adverse events between the siltartoxatug (38.2%, 168 of 440) and HTIG (33.9%, 75 of 221) groups. These findings highlight siltartoxatug as an effective and safe option for passive immunization against tetanus. ClinicalTrials.gov registration: NCT05664750.
In trauma first aid, rapid hemostasis is a priority, extricating patients from hemorrhagic shock and infection risks. This paper explores novel hemostatic materials, using ion-crosslinking and freeze-drying techniques. Iterative experiments determined optimal conditions for the temperature-variable mixing-freeze-drying chemical reaction of sodium alginate (SA)/silk fibroin (SF). We used SA, SA/SF, SA/SF-TB and commercial hemostatic sponge control samples to perform hemostasis experiments on rat liver injury and femoral artery injury models, and to perform wound healing experiments on rat back full-layer skin. The results showed that the hemostatic time and blood loss of SA/SF-TB group rats (liver hemorrhage model: 397.17 ± 34.80 mg, 77.83 ± 7.41 s; Femoral artery bleeding model: 940.33 ± 41.93 mg, 96.83 ± 4.07 s) was significantly better than other experimental groups, and similar to the commercial group. The wound healing experiment showed that the new granulation tissue thickness of SA/SF-TB group was thicker (380.39 ± 28.56 μm) at day 14. In addition, the material properties and biocompatibility of sponges were characterized by cell experiments and in vivo embedding experiments. All the results showed that the SA/SF-TB hemostatic sponge prepared in this study could not only seal the wound quickly and stop bleeding, but also promote the growth of epidermal cells and fibroblasts and accelerate wound healing. This new material solves the shortcomings of traditional materials such as low stability, limited shelf life, high unit price, and has good biocompatibility, easy preparation, rapid hemostasis and other excellent properties. Therefore, this innovative hemostatic material has great prospects and potential in clinical applications.