Estudo clínico piloto do efeito de membranas contendo ácido úsnico incorporado em lipossomas no tratamento de queimados

Abstract

Burns are traumatic wounds that cause partial or total destruction of the skin, and can reach deeper layers. The healing process can be favored by a matrix of gelatin combined with liposome, which allows the incorporation of synthetic drugs, such as unic acid, to have antimicrobial and anti-inflammatory activity, being released in a controlled way in the damaged tissue. In this perspective, the objective of this research was to evaluate the effect of the liposome-embedded gelic membrane containing liposomes (P1QLS08) compared to the silver sulfadiazine ointment, a reference product used in the hospital's clinical practice for the burn healing process In humans. This study is a pilot, controlled and randomized clinical trial developed at the Burn Treatment Unit (UTQ) of Sergipe Emergency Hospital (HUSE). Thirty patients were studied, being the patient his own control. The areas for analysis were randomly selected, one area called test (membrane administration) and another called control (treated with silver sulfadiazine ointment). Initially, an analysis was performed in 15 patients for microbiological evaluation, macroscopic observation to follow the lesions, such as skin changes and possible complaints of patients during 7, 14 and 21 days after administration of the products. At the determined times, standardized photographic records were made of both the test area and the control area. The second stage of the study corresponded to the evaluation of 15 patients, following the same methodological criteria, using the analysis by ImageJ®, in order to obtain a quantitative evaluation. With the execution of this research, the efficacy of the bioactive membrane P1QLS08 was verified in humans, because it presented evident antimicrobial action and better quality of the cicatrization. The Vancouver scale assessment showed a difference between the groups, observing a better aspect of the scar in the test areas. The courage equipment showed greater elasticity, lower tissue damage and lower level of erythema in the test areas compared to the control area. Thus, the P1QLS08 membrane effectively contributes to the development of a new product of clinical importance in accelerating the biological events associated with healing in burn patients.