TECHNIQUE OF EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION OBTAINED BY THE FLEXIBLE LIVER RETRACTOR IN BARIATRIC SURGERY: A RANDOMIZED CONTROLLED TRIAL. / TÉCNICA DE EXPOSIÇÃO DA JUNÇÃO ESOFAGOGÁSTRICA OBTIDA POR MEIO DE AFASTADOR FLEXÍVEL DE FÍGADO EM CIRURGIA BARIÁTRICA: ENSAIO CLÍNICO RANDOMIZADO.

AIM: In the Roux-en-Y gastric bypass technique, classic laparoscopic surgical retractors are usually rigid, require an additional incision for its installation, or must be handled by an assistant during the surgical procedure, involving a risk of liver injury. The aim of this study was to evaluate and validate a technique of the esophagogastric junction exposure obtained by the flexible liver retractor in bariatric surgery, comparing its efficacy with the retractor classically used for this purpose. METHODS: This study was performed as a randomized, open, prospective, controlled, and comparative design in patients with medical indications of bariatric surgery. The subjects were distributed in the classic (control) and flexible (test) retractor groups. RESULTS: A total of 100 patients (n=50 control group, n=50 test group) were included. No statistically significant difference was observed in the mean duration of surgery. Regarding visibility, 100% of the patients in the flexible retractor group demonstrated an optimal visibility level, although without statistical significance concerning the classic retractor group (94%). Invariably, carrying a trocar was necessary when using the classic retractor. CONCLUSIONS: The flexible liver retractor is safe, effective, ergonomic, and inexpensive. Furthermore, it presented a satisfactory aesthetic profile, and the use of specific instruments, new adaptation curve, and training for its handling were not required.

OBJETIVOS: Os afastadores clássicos de cirurgia laparoscópica são geralmente rígidos, necessitando de uma incisão adicional para sua instalação ou de um auxiliar para manuseio durante o ato cirúrgico e ainda, podem envolvem risco de injúria hepática. Avaliar e validar uma técnica de exposição da junção esofagogástrica obtida pelo afastador flexível de fígado em cirurgia bariátrica comparando sua eficácia com a de afastador classicamente utilizado para este fim. MÉTODOS: Tratou-se de um estudo prospectivo, aberto, controlado e comparativo em pacientes com indicação de cirurgia, distribuídos de forma randomizada em dois grupos: clássico (controle) e afastador flexível (teste). RESULTADOS: Foram incluídos 100 pacientes (n=50 grupo controle, n=50 grupo teste), sem diferença estatística na distribuição por idade e por morbidades, havendo diferença estatística somente no gênero (grupo controle obteve proporção maior de homens, p=0,020). Em relação ao tempo médio de realização das operações, não foi constatada diferença estatística. No quesito visibilidade, verificou-se que 100% dos pacientes do grupo afastador flexível obteve nível de visibilidade ótima, porém sem significância estatística com relação ao grupo clássico (94%). Invariavelmente, foi necessário um portal a mais de trocarte quando do uso do afastador clássico. CONCLUSÃO: O afastador flexível de fígado demonstrou-se seguro, eficaz, ergonômico, de baixo custo, de perfil estético satisfatório, não requerendo instrumental específico para uso ou nova curva de adaptação e aprendizado para manuseio.

A Randomized Comparison Study of Lyophilized Nile Tilapia Skin and Silver-Impregnated Sodium Carboxymethylcellulose for the Treatment of Superficial Partial-Thickness Burns.

Glycerolized Nile tilapia skin (NTS) showed promising results when used for burn treatment in phases II and III randomized controlled trials. This pilot study aims to evaluate the effectiveness of lyophilized NTS (LNTS) as a temporary skin substitute for superficial partial-thickness burns by comparing it with silver-impregnated sodium carboxymethylcellulose dressing. This was a randomized, prospective, open-label, and controlled pilot study conducted in Fortaleza, Brazil, from April 2019 to December 2019. The 24 participants had ≥18 and ≤70 years of age and superficial partial-thickness burns affecting up to 10% of TBSA. Primary outcomes were the number of dressings performed and pain intensity, assessed via the Visual Analogue Scale and the Electronic von Frey. Secondary outcomes were the level of pain-related anxiety, assessed via the Burns Specific Pain Anxiety Scale, and analgesic consumption. In the test group, the number of dressings and the patient-reported pain after dressing-related procedures were lower. Analgesic intake, pain-related anxiety, and both patient-reported and objectively measured pain before dressing-related procedures were similar for the treatment groups. No adverse effects were detected. LNTS shares the same characteristics of an "'ideal'" wound dressing demonstrated by glycerolized NTS in previous studies. Also, it demonstrated noninferiority for burn management when compared with silver-impregnated sodium carboxymethylcellulose dressing. The safety and efficacy of LNTS demonstrated in this pilot study may allow the development of larger phases II and III RCTs in a near future.

Técnica de exposição da junção esofagogástrica obtida por meio de afastador flexível de fígado em cirurgia bariátrica: ensaio clínico randomizado / Technique of exposure of the esophagogastric junction obtained by the flexible liver retractor in bariatric surgery: a randomized controlled trial

RESUMO - RACIONAL: Os afastadores clássicos de cirurgia laparoscópica são geralmente rígidos, necessitando de uma incisão adicional para sua instalação ou de um auxiliar para manuseio durante o ato cirúrgico e ainda, podem envolvem risco de injúria hepática. OBJETIVOS: Avaliar e validar uma técnica de exposição da junção esofagogástrica obtida pelo afastador flexível de fígado em cirurgia bariátrica comparando sua eficácia com a de afastador classicamente utilizado para este fim. MÉTODOS: Tratou-se de um estudo prospectivo, aberto, controlado e comparativo em pacientes com indicação de cirurgia, distribuídos de forma randomizada em dois grupos: clássico (controle) e afastador flexível (teste). RESULTADOS: Foram incluídos 100 pacientes (n=50 grupo controle, n=50 grupo teste), sem diferença estatística na distribuição por idade e por morbidades, havendo diferença estatística somente no gênero (grupo controle obteve proporção maior de homens, p=0,020). Em relação ao tempo médio de realização das operações, não foi constatada diferença estatística. No quesito visibilidade, verificou-se que 100% dos pacientes do grupo afastador flexível obteve nível de visibilidade ótima, porém sem significância estatística com relação ao grupo clássico (94%). Invariavelmente, foi necessário um portal a mais de trocarte quando do uso do afastador clássico. CONCLUSÃO: O afastador flexível de fígado demonstrou-se seguro, eficaz, ergonômico, de baixo custo, de perfil estético satisfatório, não requerendo instrumental específico para uso ou nova curva de adaptação e aprendizado para manuseio.

ABSTRACT - BACKGROUND: In the Roux-en-Y gastric bypass technique, classic laparoscopic surgical retractors are usually rigid, require an additional incision for its installation, or must be handled by an assistant during the surgical procedure, involving a risk of liver injury. Aim: The aim of this study was to evaluate and validate a technique of the esophagogastric junction exposure obtained by the flexible liver retractor in bariatric surgery, comparing its efficacy with the retractor classically used for this purpose. Methods: This study was performed as a randomized, open, prospective, controlled, and comparative design in patients with medical indications of bariatric surgery. The subjects were distributed in the classic (control) and flexible (test) retractor groups. Results: A total of 100 patients (n=50 control group, n=50 test group) were included. No statistically significant difference was observed in the mean duration of surgery. Regarding visibility, 100% of the patients in the flexible retractor group demonstrated an optimal visibility level, although without statistical significance concerning the classic retractor group (94%). Invariably, carrying a trocar was necessary when using the classic retractor. Conclusions: The flexible liver retractor is safe, effective, ergonomic, and inexpensive. Furthermore, it presented a satisfactory aesthetic profile, and the use of specific instruments, new adaptation curve, and training for its handling were not required.

Tratamento de queimaduras de segundo grau profundo em abdômen, coxas e genitália: uso da pele de tilápia como um xenoenxerto / Treatment of deep second-degree burns on the abdomen, thighs, and genitalia: use of tilapia skin as a xenograft

A pele de tilápia possui microbiota não infecciosa e estrutura morfológica semelhante à pele humana. Estudos clínicos fase II, ainda não publicados, mostraram resultados promissores na sua utilização para tratamento de queimaduras. Nos protocolos destes estudos, pacientes com lesões em áreas de dobras de pele, como genitais e região inguinal, foram excluídos, pois achava-se que o biomaterial não aderiria apropriadamente, resultando em um grau de cicatrização inferior. Relato de caso de paciente do sexo feminino, 18 anos, sem comorbidades, com queimaduras de segundo grau profundo em abdômen, região inguinal, parte da genitália e metade superior de ambas as coxas, envolvendo 13,5% da área total da superfície corporal. A pele de tilápia foi aplicada nas lesões levando a uma reepitelização completa com 16 dias de tratamento. Não foram observados efeitos colaterais. A pele de tilápia traz, portanto, a promessa de um produto inovador, de fácil aplicação e alta disponibilidade, que pode se tornar a primeira pele animal nacionalmente estudada e registrada pela Agência Nacional de Vigilância Sanitária, para uso no tratamento de queimaduras. Este relato de caso contribui para reduzir as limitações em relação às áreas anatômicas apropriadas para a aplicação da pele de tilápia, uma vez que, mesmo com a necessidade de reposição de pele, foram obtidos bons resultados com aplicação na genitália e região inguinal.

Tilapia skin has a non-infectious microbiota and a morphological structure similar to human skin. Phase II clinical studies, not yet published, have shown promising results in their use for the treatment of burns. In the protocols of these studies, patients with lesions in areas of skin folds, such as genitals and inguinal regions, were excluded, as it was thought that the biomaterial would not adhere properly, resulting in a lower degree of healing. Case report of a female patient, 18 years old, without comorbidities, with deep second-degree burns in the abdomen, inguinal region, part of the genitalia and upper half of both thighs, involving 13.5% of the total body surface area. Tilapia skin was applied to the lesions leading to a complete re-epithelialization with 16 days of treatment. No side effects were observed. Tilapia skin, therefore, brings the promise of an innovative product, easy to apply, and highly available, which can become the first animal skin nationally studied and registered by the Agência Nacional de Vigilância Sanitária, for use in the treatment of burns. This case report contributes to reduce the limitations concerning the anatomical areas appropriate for the application of tilapia skin, since, even with the need for skin replacement, good results were obtained with application to the genitalia and inguinal region.

Concurrent validity of electronic von Frey as an assessment tool for burn associated pain.

An important challenge in pain assessment is the inability of an evaluator to corroborate, using objective signs or indicators, the subjective pain report of a patient. In this scenario, the Electronic von Frey (EVF) anaesthesiometer rises as a valuable Quantitative Sensory Testing modality for pain evaluation. Although EVF showed good reproducibility when applied to healthy areas in humans, its use for evaluation of burn-related pain threshold has not yet been validated. The present study demonstrated the concurrent validity of EVF by determining its correlation with the traditionally used Visual Analog Scale (VAS). EVF was compared to VAS through pain measurements obtained from 44 patients with superficial partial thickness burns treated with silver sulfadiazine. A very good and significant positive correlation between both methods was detected. Baseline clinical and demographic parameters did not significantly affect the association between EVF and VAS. Additionally, EVF had significant and moderate positive correlation with the amount of analgesic used and with the Burns Specific Pain Anxiety Scale scores. Regular pain assessment is essential for the establishment of an appropriate treatment plan; thus, it is critical that we continue to refine our pain assessment skills to avoid chronic pain and psychological trauma in burn patients.

Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial Partial-Thickness Wounds: A Pilot Study.

This study aims to evaluate the efficacy of Nile tilapia skin as a xenograft for the treatment of partial-thickness burn wounds in children. This is an open-label, monocentric, randomized phase II pilot study conducted in Fortaleza, Brazil. The study population consisted of 30 children between the ages of 2 and 12 years with superficial "partial-thickness" burns admitted less than 72 hours from the thermal injury. In the test group, the tilapia skin was applied. In the control group, a thin layer of silver sulfadiazine cream 1% was applied. Tilapia skin showed good adherence to the wound bed, reducing the number of dressing changes required, the amount of anesthetics used, and providing benefits for the patients and also for healthcare professionals, by reducing the overall work load. The number of days to complete burn wound healing, the total amount of analgesics required throughout the treatment, burn improvement on the day of dressing removal, and pain throughout the treatment were similar to the conventional treatment with silver sulfadiazine. Thus, tilapia skin can be considered an effective and low-cost extra resource in the therapeutic arsenal of pediatric superficial partial thickness burns.

Uso da pele de tilápia do Nilo em medicina regenerativa: Status atual e perspectivas futuras / Nile tilapia fish skin use in regenerative medicine: Current status and future perspectives

OBJETIVO: O presente estudo tem como objetivo apresentar a trajetória do desenvolvimento da pele de tilápia como curativo biológico. MÉTODO: Descrição do processo de desenvolvimento da pele de tilápia como curativo biológico, desde a concepção da ideia para utilização no tratamento de queimaduras, até as perspectivas de sua utilização como scaffold em múltiplas especialidades médicas. RESULTADOS: Com o objetivo de oferecer uma alternativa segura, eficaz e de baixo custo para o tratamento de queimaduras, pesquisadores brasileiros desenvolveram um curativo biológico derivado da pele de tilápia. CONCLUSÃO: A pele de tilápia vem demonstrando um notável potencial como curativo biológico no tratamento de queimaduras e na medicina regenerativa.

OBJECTIVE: The present study aims to present the development trajectory of the tilapia skin as a biological dressing. METHODS: To describe the development process of tilapia skin as biological dressing, from the conception to the burn wounds treatment to the perspectives of its use as a scaffold in multiple medical specialties. RESULTS: In order to provide a safe, effective and low-cost alternative for the treatment of burn injuries, Brazilian researchers have recently developed a biological dressing derived from tilapia skin. CONCLUSION: The tilapia skin have been demonstrating the remarkable potential as a biological dressing in burn injuries treatment and in regenerative medicine.

Elaboração, desenvolvimento e instalação do primeiro banco de pele animal no Brasil para o tratamento de queimaduras e feridas / Elaboration, development, and installation of the first animal skin bank in Brazil for the treatment of burns and wounds

Introdução: A produção e a distribuição de pele humana pelos Bancos de Pele do Brasil é insuficiente para atender a demanda do país, suprindo menos de 1% da necessidade para tratar as vítimas de queimaduras. O objetivo do trabalho foi apresentar a elaboração e o desenvolvimento da implantação do primeiro Banco de Pele Animal do Brasil para tratamento da queimadura. Métodos: Trata-se de um estudo metodológico. O Banco de Pele Animal Aquático foi elaborado, desenvolvido e instalado a partir do desenvolvimento do processamento de pele da tilápia, da revisão sistemática de estudos referentes a banco de pele animal, de visitas à pscicultura em Jaguaribara-CE, da visita técnica aos bancos de pele humana no Brasil, de consulta técnica e de treinamento no Banco de Pele de Recife, da observação de todas as fases de processamento da pele de tilápia e da identificação da estrutura física da área onde ocorrem todos os processos. Resultados: Além da produção e da distribuição da pele da tilápia para os estudos em vítima de queimaduras, o banco está processando mais de 5000 peles de tilápia e encontra-se em fase de distribuição desta pele para estudos multicêntricos em outros estados e outras especialidades, que desenvolvem pesquisas nas áreas de ginecologia, ortopedia, endoscopia, estomaterapia, cirurgia vascular, odontologia e veterinária. Conclusão: este trabalho possibilitou a elaboração, o desenvolvimento e a implementação do primeiro Banco de Pele Animal do país e o primeiro Banco de Pele Aquática do mundo.

Introduction: The production and distribution of human skin by Brazilian skin banks is insufficient to meet the country's demand, supplying less than 1% of the need for treating burn victims. The objective of this work was to present the elaboration and development of the first animal skin bank of Brazil for the treatment of burns. Methods: This methodological study elaborated, developed, and installed The Aquatic Animal Skin Bank in terms of the development of tilapia skin processing after a systematic review of studies referring to animal skin banks based on visits to the pisciculture center in Jaguaribara-CE, technical visits to human skin banks in Brazil, technical consultation and training in the Recife Skin Bank, the observation of all phases of tilapia skin processing, and the identification of the physical structure of the area where the processes occur. Results: In addition to the production and distribution of tilapia skin for studies on burn victims, the bank is processing more than 5000 tilapia skin samples and is in the distribution phase of this skin for multicentric studies in other states and specialties including gynecology, orthopedics, endoscopy, stomatherapy, vascular surgery, dentistry, and veterinary medicine. Conclusion: This work enabled the elaboration, development, and implementation of Brazil's first animal skin bank and the world's first aquatic skin bank.

Innovative treatment using tilapia skin as a xenograft for partial thickness burns after a gunpowder explosion.

Tilapia skin has non-infectious microbiota, high amounts of type I collagen, and similar morphological structure to human skin, so it has been suggested as a potential xenograft for the management of burn wounds. A 23-year-old male patient, with no comorbidities, arrived at our burn treatment center after a thermal injury caused by contact with flames from a gunpowder explosion. Superficial partial thickness burns were present in his right upper limb and deep partial thickness burns were present in his left upper limb. Tilapia skin was applied to the lesions, leading to complete reepithelialization within 12 and 17 days of treatment, respectively. No dressing changes were needed and no side effects were observed. Tilapia skin carries the promise of an innovative, easy-to-apply and highly available product that can become the first nationally studied animal skin registered by the National Sanitary Surveillance Agency for use in the treatment of burns.

Use of Tilapia Skin as a Xenograft for Pediatric Burn Treatment: A Case Report.

Burns represent the fifth most common cause of nonfatal childhood injuries in the world. The Nile tilapia skin (Oreochromis niloticus) is widely available in Brazil and demonstrated, in previous studies, noninfectious microbiota, morphological structure similar to that of human skin, and good outcomes when used as a xenograft for treatment of experimental burns in rats. A 3-year-old boy was admitted to a burn treatment center in Fortaleza, Brazil, with scalds in the left side of the face, neck, anterior thorax, abdomen, and left arm. Involvement of 18% of total body surface area with superficial partial thickness burns was calculated. After local Institutional Review Board approval and written permission from the patient's legal caregiver were obtained, application of tilapia skin as an occlusive dressing was performed. Good adherence of tilapia skin to the wound bed was detected. The patient was discharged from the hospital with a total of 10 days required for the complete re-epithelialization of his superficial partial thickness burn. No adverse effects were noted. We believe that further studies conducted by our researchers will allow this innovative, low-cost, widely available and easy to apply biomaterial to firm itself as a relevant option in the therapeutic arsenal of pediatric burns, producing significant social and financial impact for the health system.

Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin.

BACKGROUND: Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs, such as antibiotics. The pharmacokinetics of oral amoxicillin after Roux-en-Y gastric bypass (RYGB) surgery is unknown. OBJECTIVES: The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin. METHODS: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n = 8) received an amoxicillin 500 mg capsule orally before and 2 months after the RYGB surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS). RESULTS: After the surgery, the mean weight loss was 17.03 ± 5.51 kg, and mean body mass index (BMI) decreased from 46.21 ± 2.82 to 38.82 ± 3.32 kg/m2. The mean amoxicillin area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC0-tlast) increased significantly (3.5-fold); the maximum plasma concentration (Cmax) increased 2.8-fold after the bariatric surgery. No correlation was found between amoxicillin absorption, BMI, and weight loss percentage. CONCLUSION: The alterations observed in the amoxicillin pharmacokinetics suggest that obese subjects included in this trial had a substantially increase in amoxicillin systemic exposure after RYGB surgery. However, despite this increase, its exposure was lower than the values reported for non-obese volunteers. TRIAL REGISTRATION: Identifiers: NCT03588273.

Elaboração de um protocolo para implementação e funcionamento do primeiro banco de pele animal do Brasil: Relato de experiência / Preparation of a protocol for the implementation and functioning of the first animal skin bank of Brazil: Experience report / Elaboración de un protocolo para implementación y funcionamiento del primer banco de piel animal de Brasil: Relato de experiencia

Objetivo: Elaborar um protocolo para implementação e funcionamento do primeiro banco de pele animal do Brasil. Resultados: Para a construção do protocolo, até o presente momento, foram realizadas as seguintes etapas: visita técnica ao Banco de Pele Animal de Recife, onde foi traçado o levantamento das necessidades de insumos, controle de esterilização e organização do ambiente; identificação e descrição de todas as etapas do processamento da pele de tilápia; elaboração de planilhas de relação de materiais necessários para o processamento da pele de tilápia; e controle do gasto de material utilizado. Conclusão: Frente à incontestável importância e ineditismo da concepção do primeiro Banco de Pele Animal do Brasil e o primeiro para pele de animal aquática no mundo, o papel do enfermeiro é fundamental para a elaboração e implantação de um protocolo que, por meio de um gerenciamento adequado, assegure o estabelecimento de regras, uniformização dos procedimentos e rotinas de processo. Este trabalho permitirá a criação de manuais e controles que irão nortear os processos e garantir a qualidade de todas as etapas do processamento da pele da tilápia do primeiro Banco de Pele Animal do Brasil.

Objective: Elaboration of a protocol for the implementation and operation of the first animal skin bank in Brazil. Results: For development of the protocol, until now, the following steps were taken: technical visit to Recife Skin Bank and consulting the head nurse, where it was traced the supplies needs assessment, sterilization control and environmental organization; identification and description of all stages of tilapia skin processing; elaboration of spreadsheets regarding a list of materials necessary for the processing of tilapia skin and control of the expenditure of the material employed. Conclusion: Before of the undeniable importance and the conception originality of the first Animal Skin Bank of Brazil and the first for aquatic animal skin in the world, the role of a nurse becomes key piece to design and implement a protocol that, through adequate management, ensure the establishment of rules, standardization of procedures and process routines. This work will allow the creation of manuals and controls that will guide the processes and guarantee the quality of all stages of the skin processing of tilapia of the first Animal Skin Bank of Brazil.

Objetivo: Elaborar un protocolo para la implementación y el funcionamiento del primer banco de piel animal de Brasil. Resultados: Para el desarrollo del protocolo, hasta el presente momento, se realizaron las siguientes etapas: visita técnica al Banco de Piel de Recife y consultoría por la enfermera jefe, donde fue trazado el levantamiento de las necesidades de insumos, control de esterilización y organización del ambiente identificación y descripción de todas las etapas del procesamiento de la piel de tilapia; elaboración de planillas de relación de materiales necesarios para el procesamiento de la piel de tilapia y control del gasto de material utilizado. Conclusión: El papel del enfermero es fundamental, para la elaboración e implantación de un protocolo que, a través de una gestión adecuada, asegure el establecimiento de reglas, uniformidad de los procedimientos y rutinas de proceso. Este trabajo permitirá la creación de manuales y controles para orientar los procesos y garantizar la calidad de todas las etapas del procesamiento de la piel de la tilapia del Primer Banco de Piel Animal de Brasil.