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PAGES: 71-79 DOI: 10.1590/0074-027601700125 Full paper
Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Rosiana Estéfane da Silva1, Janaína de Pina Carvalho1, Dario Brock Ramalho1, Maria Camilo Ribeiro de Senna1, Hugo Silva Assis Moreira1, Ana Rabello1, Erika Cota2, Gláucia Cota1,+

1Fundação Oswaldo Cruz-Fiocruz, Centro de Pesquisas René Rachou, Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil
2Universidade Federal do Rio Grande do Sul, Instituto de Informática, Porto Alegre, RS, Brasil


BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects.

OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure.

METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed.

FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result.

CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

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Financial support: CNPq (Universal/project number 405407/2016-5).
AR is supported by CNPq (grant 311641/2009-1).
+ Corresponding author: This e-mail address is being protected from spambots. You need JavaScript enabled to view it.
Received 31 March 2017
Accepted 5 July 2017