Uso transoperatório tópico do ácido tranexâmico em cirurgia plástica reconstrutora em tumores faciais: Ensaio clínico randomizado
Efficacy and safety of topical application of tranexamic acid in patients undergoing reconstructive plastic surgery after excision of facial skin cancers: a randomised clinical trial
Victor Felipe dos Santos Tejada; Linjie Zhang; Luciano Zogbi
Resumo
Introdução: o ácido tranexâmico (AT) ganhou reconhecimento em diversas especialidades cirúrgicas na prevenção sangramentos e complicações associadas, porém seu uso na cirurgia plástica ainda é limitado. O objetivo deste estudo foi avaliar a eficácia e segurança do uso tópico do AT na cirurgia reparadora oncológica da face e escalpo.
Metodologia: foi realizado um ensaio clínico randomizado, duplo-cego, em pacientes maiores de 18 anos, portadores de neoplasias malignas de pele na região da cabeça (CID10 C44.9). Os desfechos avaliados foram volume de perda sanguínea no pós-operatório imediato, hemorragia transoperatória de difícil controle, hematomas, equimoses, isquemia, necrose de tecidos, infecção de ferida operatória, efeitos tromboembólicos e outras intercorrências.
Resultados: foram incluídos 54 pacientes, 26 no grupo AT e 28 no grupo placebo. O sangramento médio foi de 11,42ml, DP 6,40 (8,83 a 14,01) no grupo AT e de 17,6ml, DP 6,22 (15,19 a 20,01) no grupo controle, representando uma diminuição média de 6,18ml (35,11%) nas perdas sanguíneas (p=0,001). O AT reduziu significativemente o risco de equimoses (grupo AT: 1/26, 3,9% vs. grupo placebo: 23/28, 82,1%; p=0,000), representando uma redução relativa de 95,4% (RR=0,046; IC de 95%: 0,007-0,323). Houve dois casos de isquemia cutânea e um caso de necrose no grupo placebo, sem outras complicações no grupo AT.
Conclusão: o uso tópico do AT foi efetivo na redução do sangramento transoperatório e pós-operatório imediato, com importante diminuição no risco de equimoses, não sendo evidenciados sofrimento isquêmico de retalhos, complicações sistêmicas tromboembólicas ou outros eventos adversos.
Palavras-chave
Abstract
Introduction: Tranexamic acid (TA) has attracted increased attention among surgical specialties, but its use in plastic surgery is limited. The aim of this study was to assess the efficacy and safety of topical administration of 3% TA solution in reconstructive surgery of the face and scalp after excision of skin cancers.
Methods: a randomized, double-blind, parallel-group clinical trial was conducted in patients aged 18 years or older with malignant skin neoplasms in the face or scalp region (ICD-10 C44.9). The primary outcome was volume of blood loss in the intraoperative and immediate postoperative period. Secondary outcomes included difficult-to-control intraoperative haemorrhage, hematoma, ecchymosis, and other adverse events.
Results: of the 54 included patients, 26 were randomised to TA group and 28 to placebo group. The mean blood loss was 11.42ml (SD 6.40, range 8.83-14.01) in the TA group, and 17.6ml (SD 6.22, range 15.19-20.01) in the placebo group, representing a mean decrease of 6.18ml (35.11%) (p=0.001). TA significantly reduced the risk of ecchymosis (RR = 0.046; 95% CI: 0.007-0.323). Only two patients in the placebo group experienced ischemia in the flaps, and one patient in the placebo group experienced tissue necrosis requiring surgical reintervention. There were no surgical wound infections, thromboembolic phenomena, or other adverse events related to TA.
Conclusions: topical TA may reduce intraoperative and immediate postoperative bleeding, with a significantly decreased risk of ecchymosis. There is no evidence of ischemic damage of flaps, systemic thromboembolic complications, or other adverse events.
Keywords
Referências
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Submetido em:
02/04/2024
Aceito em:
05/05/2024
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