Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Silva, Rosiana Estéfane da; Carvalho, Janaína de Pina; Ramalho, Dario Brock; Senna, Maria Camilo Ribeiro De; Moreira, Hugo Silva Assis; Rabello, Ana; Cota, Erika; Cota, Gláucia

doi:10.1590/0074-027601700125

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Article • Mem. Inst. Oswaldo Cruz 113 (2) • Feb 2018 • https://doi.org/10.1590/0074-027601700125 linkcopy

Towards a standard protocol for antimony intralesional infiltration technique for cutaneous leishmaniasis treatment

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

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.

Key words:
cutaneous leishmaniasis; therapy; meglumine antimoniate; intralesional infiltration; validation

	Professionals without prior experience in therapy IL (Number of procedures: 29; number of professionals: 14)	Professionals with previous experience in therapy IL (Number of procedures: 89; number of professionals: 3)	p value
Time spent with the procedure in minutes (median, min-max)	13.5 (4-21)	12 (3-35)	0.21**
100% adhesion to the SOP	11/29 (38%)	67/89 (75%)	0.00*
Pain VAS scoring above 3	8/29 (28%)	25/89 (28%)	1*
Bleeding FBS scoring above 3	4/29 (14%)	35/89 (39%)	0,01*
Local anesthesia administration before infiltration	27/29 (93%)	77/89 (87%)	0.51*
Needle insertion from intact skin	26/29 (89%)	77/89 (87%)	1*
Complete ampoule contents aspiration before starting the infiltration	24/29 (83%)	75/89 (84%)	1*
Needle insertion from anesthetic button	27/29 (93%)	77/89 (87%)	0.51*
Needle position toward the center of the lesion	28/29 (97%)	85/89 (97%)	1*
Needle tilt parallel to the base of the lesion	18/29 (66%)	76/89 (85%)	0.02*
Placement of the bevel of the needle facing up	27/29 (97%)	89/89 (100%)	0.15*
Slow drug infiltration while rewinding the needle	26/29 (89%)	85/89 (96%)	0.36*
Understanding of the concept of saturation as swelling of the lesion	27/29 (93%)	89/89 (100%)	0.06*
Maximum drug limit per day was observed	29/29 (100%)	89/89 (100%)	-

	Pain VAS scoring until 3 (referred after 86 procedures)	Pain VAS scoring above 3 (referred after 32 procedures)	p value*
Local anesthesia administration not performed before infiltration	7/86 (8%)	7/32 (28%)	0.06
Needle insertion not performed from intact skin	7/86 (8%)	8/32 (25%)	0.03
Needle insertion not performed from anesthetic button	7/86 (8%)	7/32 (22%)	0.06

	The first 44 infiltrations performed by medical doctor seniors	The latest 45 infiltrations performed by medical doctor seniors	p value*
Time spent with the procedure in minutes (median, min-max)	11 (3-27)	12 (4-35)	0.11
Complete adhesion to the SOP	26/44 (59%)	41/45 (91%)	0.00
Pain referred by patient above 3 or mild pain	19/44 (43%)	6/45 (13%)	0.01
Bleeding FBS scoring above 3	22/44(50%)	13/45 (29%)	0.22

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[TFN1] FBS: modified Fromme-Boezaart scale; IL: intralesional; SOP: standard operational procedure; VAS: visual analogue scale;

[TFN2] ^*
p value is computed using chi-square test;

[TFN3] ^**
p value is computed using one-way ANOVA test.