RBR-3nvyrtg Use of Laser Therapy to improve Infection at the site (jararaca) Snake Bite in the Brazilian Amazon

Date of registration: 04/24/2025 ^(mm/dd/yyyy)
Last approval date : 04/24/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1320-8353

• Public title:

  en

  Use of Laser Therapy to improve Infection at the site (jararaca) Snake Bite in the Brazilian Amazon

  pt-br

  Uso de Laserterapia para melhorar Infecção no local de Picada de Cobra (jararaca) na Amazônia Brasileira

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 77856324.2.0000.5016
    Issuing authority: Plataforma Brasil
  • 6.692.336
    Issuing authority: Comitê de Ética em Pesquisa da Universidade do Estado do Amazonas

Sponsors

• Primary sponsor: Escola Superior de Ciências da Saúde da Universidade do Estado do Amazonas
• Secondary sponsor:
  • Institution: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
  • Institution: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Health conditions

• Health conditions:

  en

  Snake Bites

  pt-br

  Mordeduras de Serpentes

• General descriptors for health conditions:

  en

  C01 Infections

  pt-br

  C01 Infecções

• Specific descriptors:

  en

  C25.723.127.442 Snake Bites

  pt-br

  C25.723.127.442 Mordeduras de Serpentes

Interventions

• Interventions:

  en

  This is a randomized, controlled, double-blind, two-arm clinical trial. The population considered for this study corresponds to patients treated at the Dr. Heitor Vieira Dourado Tropical Medicine Foundation (FMT-HVD) who were victims of Bothrops accidents. Patients diagnosed with envenomation will be classified according to the institution's routine and the Ministry of Health protocol for administration of serum therapy. Study intervention: 106 patients admitted to the hospital after envenomation will receive conventional and laser treatment within 30 minutes after infusion of antivenom at a dose of 4 j/cm2 (T1 - first phase), subsequently performed within 24 hours (T2 - second phase) and 48 hours (T3 - third phase) after the first application. Control intervention: 106 patients hospitalized after poisoning will receive conventional treatment and will also receive the laser (but with the device turned off, therefore without any effect) within 30 minutes after the infusion of antivenom serum (T1 - first phase), performed later in 24 hours (T2 - second phase) and 48 hours (T3 - third phase) after the first application. Patients in both groups will be clinically evaluated for 4 days (admission, 24h, 48h and 72h) by a team that will not know which patients received the laser or not. The laser application will be performed by the researcher responsible for the project. The patients will be blinded, because during the laser application procedure (or with the device turned off) they will wear two protective glasses through which it is impossible to see the light. Randomization will be performed randomly by means of a computer program by the supervisor, and the researcher responsible for the laser application will be revealed only after confirmation of the patient's inclusion in the study.

  pt-br

  Trata-se de um ensaio clínico randomizado, controlado, duplo-cego, de dois braços. A população considerada para este estudo corresponde aos pacientes atendidos na Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (FMT-HVD) vítimas de acidentes botrópicos. Os pacientes com diagnóstico de envenenamento serão classificados conforme a rotina da instituição e o protocolo do Ministério da Saúde para administração de soroterapia. Intervenção do estudo: 106 pacientes internados no hospital após envenenamento receberão tratamento convencional e a laser em até 30 minutos após a infusão do antiveneno na dose de 4 j/cm2 (T1 - primeira fase), posteriormente realizado em até 24 horas (T2 - segunda fase) e 48 horas (T3 - terceira fase) após a primeira aplicação. Intervenção controle: 106 pacientes internados após intoxicação receberão tratamento convencional e também receberão o laser (mas com o aparelho desligado, portanto sem efeito algum) em até 30 minutos após a infusão do soro antiveneno (T1 - primeira fase), realizada posteriormente em 24 horas (T2 - segunda fase) e 48 horas (T3 - terceira fase) após a primeira aplicação. Os pacientes de ambos os grupos serão avaliados clinicamente por 4 dias (admissão, 24h, 48h e 72h) por uma equipe que não saberá quais pacientes receberam ou não o laser. A aplicação do laser será realizada pelo pesquisador responsável pelo projeto. Os pacientes serão cegados, pois durante o procedimento de aplicação do laser (ou com o aparelho desligado) usarão dois óculos de proteção através dos quais é impossível enxergar a luz. A randomização será realizada aleatoriamente por meio de programa de computador pelo supervisor, e o pesquisador responsável pela aplicação do laser será revelado somente após a confirmação da inclusão do paciente no estudo.

• Descriptors:

  en

  E02.594 Laser Therapy

  pt-br

  E02.594 Terapia a Laser

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 06/01/2024 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  212	-	0	0

• Inclusion criteria:

  en

  Present clinical characteristics of a Bothrops snakebite accident, regardless of sex and age; have occurred less than 24 hours before the snakebite accident; have not undergone serum therapy for a current Bothrops snakebite accident in another institution; no minimum age was defined, however, in relation to children, only those who understand the procedure, agree to participate in the research together with their legal guardian and who understand/accept the use of protective glasses will be included

  pt-br

  Apresentar características clínicas de acidente ofídico botrópico, independentemente do sexo e idade; ter ocorrido há menos de 24 horas do acidente ofídico; não ter realizado soroterapia para acidente botrópico atual em outra instituição; não foi definida idade mínima, porém, em relação às crianças, serão incluídas somente aquelas que entenderem o procedimento, concordarem em participar da pesquisa juntamente com seu responsável legal e que entenderem/aceitarem o uso de óculos de proteção

• Exclusion criteria:

  en

  Patients who have a clearly established secondary infection at the time of admission; immunocompromised patients, those with autoimmune disease or microorganisms that compromise the immune system; who have used antibiotics in the last 30 days

  pt-br

  Pacientes que apresentem infecção secundária claramente estabelecida no momento da admissão; pacientes imunocomprometidos, portadores de doença autoimune ou microrganismos que comprometam o sistema imunológico; que tenham utilizado antibióticos nos últimos 30 dias

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: Reduction of secondary infection at the site of the bite: cellulitis and/or abscess is expected with the use of low-intensity laser therapy up to 72 hours. Secondary infection will have the following diagnostic criteria: Cellulitis will be defined by the presence of signs of local inflammation (erythema, edema, bruising and pain) associated with fever, leukocytosis, lymphangitis and/or lymphadenitis. The abscess will be characterized by individual, fluctuating lesions, presenting purulent secretion or seropurulent secretion

  pt-br

  Desfecho esperado 1: Epera-se uma redução da infecção secundária no local da picada: celulite e/ou abscesso com uso da laserterapia de baixa intensidade até 72 horas. A infecção secundária terá como critério diagnóstico: A celulite será definida pela presença de sinais de inflamação local (eritema, edema, hematomas e dor) com associação a febre, leucocitose, linfangite e/ou linfadenite. O abscesso será caracterizado por lesões individuais, flutuantes, apresentando-se purulentas secreção ou secreção sero-purulenta

• Secondary outcomes:

  en

  Expected outcome 2: reduction of infection after 72 hours; reduction of other complications related to tissue lysis and local inflammation such as necrosis, improvement in range of motion, improvement in strength or weight bearing, local sensitivity and quality of life

  pt-br

  Desfecho esperado 2: redução de infecção após 72 horas; redução de outras complicações relacionadas à lise tecidual e inflamação local como necrose, melhora da amplitude de movimento, melhora de força ou descarga de peso, sensibilidade local e qualidade de vida

Data Sharing Plan

• Data Sharing Plan:

  en

  Yes

• Data Sharing Description:

  en

  The research team responsible for the study undertakes to share the collected data in anonymized form, in accordance with the ethical and legal guidelines relevant to the protection of the privacy of the participants and the scientific advancement related to snakebite accidents. The purpose of sharing anonymized data is to contribute to the advancement of scientific knowledge about the effects and treatments of snakebite accidents, aiming at the development of new treatment methods. The data collected during the research includes clinical information, such as medical history, characteristics of the snakebite accident (type of snake, time of exposure, symptoms, treatments applied, etc.), as well as demographic data of the participants. All data will be anonymized, that is, it will not be possible to individually identify any participant through the information provided. The data will be processed in a way that guarantees anonymity, with no possibility of identifying the participants. No personal information, such as name, address or contact details, will be shared. Any sensitive information that could identify the participant will be removed before sharing. The anonymized data will be made available to the scientific community for the purposes of clinical studies, treatment improvements and the development of preventive strategies. Its use will be restricted to scientific purposes and will not be directed to any commercial or personal purpose. Research participants will sign a written informed consent form, in a clear and transparent manner, authorizing the collection, use and sharing of their data in an anonymized form, in accordance with the objectives of the study. Data sharing will strictly follow current legislation, including the General Data Protection Law (LGPD), as well as ethical and scientific standards for research involving human beings. The study protocol containing the full description, objectives, methods and schedule will be available, as well as the statistical analysis plan detailing the data analysis methods, including the statistical approaches that will be used to evaluate the results. Anonymized data may be shared with academic researchers, health institutions, hospitals and scientific research organizations that demonstrate a legitimate interest and need for access for research purposes. The data will be made available through an online data repository, password-protected and with controlled access, ensuring that only authorized researchers can access it. Access will be subject to approval of a formal request, including a description of the research project and an assurance that the data will be used exclusively for scientific purposes. These documents will be made available upon request after data collection is complete

Contacts

• Public contact
  • Full name: Êndila de Souza Barbosa
  • • Address: Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus - AM
    • City: Manaus / Brazil
    • Zip code: 69065-001
  • Phone: +55 (92) 991546272
  • Email: endila.ak@gmail.com
  • Affiliation: Universidade do Estado do Amazonas
   
• Scientific contact
  • Full name: Êndila de Souza Barbosa
  • • Address: Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus - AM
    • City: Manaus / Brazil
    • Zip code: 69065-001
  • Phone: +55 (92) 991546272
  • Email: endila.ak@gmail.com
  • Affiliation: Universidade do Estado do Amazonas
   
• Site contact
  • Full name: Êndila de Souza Barbosa
  • • Address: Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus - AM
    • City: Manaus / Brazil
    • Zip code: 69065-001
  • Phone: +55 (92) 991546272
  • Email: endila.ak@gmail.com
  • Affiliation: Universidade do Estado do Amazonas
   

Additional links:

• Download in ICTRP format