Jet-injection assisted photodynamic therapy for superficial and nodular basal cell carcinoma: A pilot study.

BACKGROUND: Photodynamic therapy (PDT) with topical δ-Aminolevulinic acid (ALA) has efficacy in treating basal cell carcinoma (BCC) but is limited by incomplete penetration of ALA into the deeper dermis. This prospective open-label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI-PDT) for BCC treatment. It was performed with 15 patients (n = 15) with histologically confirmed, untreated, low-risk nodular BCCs at a single institution. METHODS: For the intervention, JI-PDT patients (n = 11) received two sessions of jet-injected ALA with PDT separated by four to 6 weeks. To further understand treatment technique, another group of patients (n = 4) received jet-injected ALA followed by tumor excision and fluorescence microscopy (JI-E). Treatment tolerability was assessed by local skin responses (LSR) score at five distinct time intervals. Fluorescence microscopy assessed protoporphyrin IX penetration depth and biodistribution within the tumor. At the primary endpoint, tumor clearance was evaluated via visual inspection, dermoscopy and reflectance confocal microscopy. Postinjection and postillumination pain levels, and patient satisfaction, were scored on a 0-10 scale. RESULTS: Fifteen participants with mean age of 58.3, who were 15/15 White, non-Hispanic enrolled. The median composite LSR score immediately after JI-PDT was 5 (interquartile range [IQR] = 3) which decreased to 0.5 (IQR = 1) at primary endpoint (p < 0.01). Immunofluorescence of excised BCC tumors with jet-injected ALA showed photosensitizer penetration into papillary and reticular dermis. Of the 13 JI-PDT tumors, 11 had tumor clearance confirmed, 1 recurred, and 1 was lost to follow-up. 1/11 patients experienced a serious adverse event of cellulitis. 70% of patients had local scarring at 3 months. Patients reported an average pain level of 5.6 (standard deviation [SD] = 2.3) during jet injection and 3.7 (SD = 1.8) during light illumination. CONCLUSIONS: Jet injection of ALA for PDT treatment of nodular low-risk BCC is tolerable and feasible and may represent a novel modality to improve PDT.

Delivery of Experimental mRNA Vaccine Encoding the RBD of SARS-CoV-2 by Jet Injection.

We studied a needle-free jet injection delivery of an experimental mRNA vaccine encoding the receptor-binding domain of the SARS-CoV-2 S protein (mRNA-RBD). Immunization of BALB/c mice with mRNA-RBD by a needle-free jet injector induced high levels of antibodies with virus-neutralizing activity and a virus-specific T-cell response. The immune response was low in the group of mice that received intramuscular injection of mRNA-RBD. The effectiveness of this simple and safe method of mRNA delivering has been demonstrated. Thus, jet injection of mRNA vaccine can be a good alternative to lipid nanoparticles.

Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial

Abstract Pain due to administration of local anesthetics is the primary reason for patients' fear and anxiety, and various methods are used to minimize it. This study aimed to measure the degree of pain during administration of anesthesia and determine the latency time and duration of pulpal anesthesia using two anesthetic methods in the maxilla. Materials and Methods: A randomized, single-blind, split-mouth clinical trial was conducted with 41 volunteers who required class I restorations in the maxillary first molars. Local anesthesia was administered with a needleless jet injection system (experimental group) or with a carpule syringe (control) using a 30-gauge short needle. The method of anesthesia and laterality of the maxilla were randomized. A pulp electric tester measured the latency time and duration of anesthesia in the second molar. Visual analogue scale (VAS) was used to measure the degree of pain during the anesthetic method. Data were tabulated and then analyzed by a statistician. The t-test was used to analyze the differences between the groups for basal electrical stimulation. Duration of anesthesia and degree of pain were compared using the Mann-Whitney test. A 5% significance level was considered. Results: There was no statistical difference in the basal electrical stimulation threshold (mA) and degree of pain between the two methods of anesthesia (p>0.05). Latency time was 2 minutes for all subjects. The duration of pulpal anesthesia showed no statistical difference (minutes) between the two methods (p<0.001), with a longer duration for the traditional method of anesthesia (median of 40 minutes). Conclusions: The two anesthetics methods did not differ concerning the pain experienced during anesthesia. Latency lasted 2 minutes for all subjects; the traditional infiltration anesthesia resulted in a longer anesthetic duration compared with the needleless jet injection.

Endoscopic gastric submucosal dissection: experimental comparative protocol between standard technique and Hybrid-Knife(r) / Dissecção endoscópica submucosa gástrica: protocolo experimental comparativo entre a técnica convencional e o Hybrid-Knife(r)

ABSTRACT Background Endoscopic treatment of superficial gastrointestinal tumors is routinely performed, however the advantages and shortcomings of submucosal pressure-jet dissection is still debated. Objective - Aiming to compare this technique with conventional submucosal dissection, a study was designed in pigs. Methods - Areas of the antral mucosa of the stomach with a diameter of 2 cm2 (6 per animal) were marked, and resected by means of the hybrid-knife (experimental technique), and Flush-knife or IT-knife (controls). An ERBE ICC 300 electrosurgical unit was adopted. End-points were procedural time, complications, and quality of the resected specimen. Results - A total of 27 interventions were conducted in five animals. Time spent with the two options was quite short, and similar: 9.5±3.1 vs 8.0±3.0 minutes (P=0.21). Complications didn't differ (three per group, not significant), and removed specimen looked adequate in both circumstances. Conclusion - The hybrid-knife technique is an acceptable alternative to submucosal dissection, showing no difference compared to the standard technique taking into consideration the procedure, the presence of complications and the quality of the resected specimen.

RESUMO Contexto O tratamento endoscópico de tumores gastrointestinais superficiais é realizado rotineiramente, no entanto as vantagens e deficiências da dissecção submucosa com jato de pressão ainda é debatido. Objetivo - Visando comparar esta técnica com dissecção submucosa convencional, um estudo foi realizado em suínos. Métodos - Áreas da mucosa antral do estômago com um diâmetro de 2 cm2 (um total de 6 por animal) foram marcadas, e a ressecção através do hybrid-knife (técnica experimental), e do Flush-knife ou IT-knife (controles). Uma unidade eletro cirúrgica ERBE ICC 300 foi adotada. Os desfechos foram: tempo do procedimento, complicações e qualidade da amostra ressecada. Resultados - Um total de 27 intervenções foram realizadas em cinco animais. O tempo gasto com as duas técnicas foi curto e semelhante: 9,5±3,1 vs 8,0±3,0 minutos (P=0,21). As complicações não diferiram (três por grupo, não significativas), e amostras retiradas foram adequadas em ambas as circunstâncias. Conclusão - A técnica de hybrid-knife é uma alternativa aceitável para dissecção submucosa, demonstrando não haver diferença em comparação à técnica convencional levando em consideração o tempo de procedimento, a presença de complicações e a qualidade da amostra ressecada.

Avaliaçäo da resistência ao cisalhamento em dentina de cimentos de ionômero de vidro convencional e modificado e duas resinas compostas, empregando-se três sistemas adesivos e duas técnicas de secagem da dentina / Evaluate the shear bond strength on dentine of conventional and modified glass ionomer cements, with the use of three adhesive systems and two drying techniques

A influência de adesivos e da umidade dentinária na resistência ao cisalhamento da uniäo entre dentina e materiais restauradores diretos foi avaliada neste trabalho. Os materiais restauradores testados foram: um cimento de ionômero de vidro convencional (Chelon-fil - ESPE), um cimento de ionômero de vidro modificado com resina (Vitremer - 3M), uma resina composta modificada com poliácidos (Dyract - Dentsply) e uma resina composta (TPH Dentsply). No trabalho foram utilizados 240 pré-molares e molares humanos extraídos, que tiveram uma de suas superfícies proximais desgastadas até se obter uma superfície plana em dentina, sobre a qual foram aplicados os sistemas adesivos e os materiais restauradores. Os espécimes foram divididos em 4 grupos experimentais. No grupo 4.3.1, a dentina foi condiconada com o adesivo próprio indicado pelo fabricante do material restaurador; no grupo 4.3.2., a dentina foi condicionada com um sistema adesivo experimental Gluma C; no grupo 4.3.3, a dentina foi condicionada com o sistema adesivo Prime & Bond 2.0 (Dentsply); e no grupo 4.3.4, a dentina foi condicionada com o sistema adesivo Scotchbond MP (3M). A técnica de secagem da dentina utilizada foi jato de ar por 5 segundos, considerada técnica seca, e lenço de papel aplicado duas vezes sobre a dentina, considerada técnica úmida. Os espécimes foram confeccionados com os materiais restauradores e os sistemas adesivos utilizados de acordo com as instruçöes dos fabricantes, armazenados em água por 24 horas e testados em máquina universal de testes KRATOS. A análise estatística mostrou que a resina composta Dyract, a melhor combinaçäo foi a do adesivo próprio na técnica úmida, que apresentou o maior resultado, de 23,36MPa. Os resultados com cimento Vitremer, utilizando-se os sistemas adesivos Prime & Bond 2.0 e o adesivo experimental Gluma C, foram de 16,45MPa e 13,58 MPa, respectivamente. Esses adesivos melhoraram significantemente a adesäo quando comparados com o adesivo próprio. Com relaçäo à técnica de secagem da dentina, a técnica úmida foi significantemente melhor que a técnica seca (p<0,01)