Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment
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 effec...
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| Format: | Article |
| Language: | English |
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Fundação Oswaldo Cruz (FIOCRUZ)
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| Series: | Memorias do Instituto Oswaldo Cruz |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000200071&lng=en&tlng=en |
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| author | Rosiana Estéfane da Silva Janaína de Pina Carvalho Dario Brock Ramalho Maria Camilo Ribeiro De Senna Hugo Silva Assis Moreira Ana Rabello Erika Cota Gláucia Cota |
| author_facet | Rosiana Estéfane da Silva Janaína de Pina Carvalho Dario Brock Ramalho Maria Camilo Ribeiro De Senna Hugo Silva Assis Moreira Ana Rabello Erika Cota Gláucia Cota |
| author_sort | Rosiana Estéfane da Silva |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T08:13:00Z |
| format | Article |
| id | doaj.art-8ae39af889a64fc1bb9754a84b4cc491 |
| institution | Directory Open Access Journal |
| issn | 1678-8060 |
| language | English |
| last_indexed | 2024-03-12T08:13:00Z |
| publisher | Fundação Oswaldo Cruz (FIOCRUZ) |
| record_format | Article |
| series | Memorias do Instituto Oswaldo Cruz |
| spelling | doaj.art-8ae39af889a64fc1bb9754a84b4cc4912023-09-02T19:06:31ZengFundação Oswaldo Cruz (FIOCRUZ)Memorias do Instituto Oswaldo Cruz1678-80601132717910.1590/0074-027601700125S0074-02762018000200071Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatmentRosiana Estéfane da SilvaJanaína de Pina CarvalhoDario Brock RamalhoMaria Camilo Ribeiro De SennaHugo Silva Assis MoreiraAna RabelloErika CotaGláucia CotaBACKGROUND 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000200071&lng=en&tlng=encutaneous leishmaniasistherapymeglumine antimoniateintralesional infiltrationvalidation |
| spellingShingle | Rosiana Estéfane da Silva Janaína de Pina Carvalho Dario Brock Ramalho Maria Camilo Ribeiro De Senna Hugo Silva Assis Moreira Ana Rabello Erika Cota Gláucia Cota Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment Memorias do Instituto Oswaldo Cruz cutaneous leishmaniasis therapy meglumine antimoniate intralesional infiltration validation |
| title | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| title_full | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| title_fullStr | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| title_full_unstemmed | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| title_short | Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| title_sort | towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment |
| topic | cutaneous leishmaniasis therapy meglumine antimoniate intralesional infiltration validation |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000200071&lng=en&tlng=en |
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