Pomada de óxido de zinco versus hidrogel no tratamento de úlcera crônica de pessoas com sequelas de hanseníase: estudo clínico randomizado do tipo piloto / Zinc oxide ointment versus hydrogel in the treatment of chronic ulcers in people with leprosy sequelae: a randomized clinical pilot study

As úlceras cutâneas crônicas de origem neuropática secundárias à hanseníase são de difícil resolução e onerosas ao sistema público de saúde e aos pacientes acometidos. Há coberturas de alta tecnologia para o tratamento das úlceras, entretanto, são de custo elevado. Desta forma, faz-se necessário identificar tratamento que possa ser usado nessa população, buscando minimizar ou regredir completamente a úlcera e que seja de baixo custo. Objetivo: Avaliar a viabilidade de um protocolo para uso da pomada de óxido de zinco nas concentrações a 20% e 25% comparada ao hidrogel, no tratamento de úlcera crônica de perna de pessoas com sequelas de hanseníase e propor instrumento de acompanhamento de pacientes em tratamento de úlceras crônicas. Método: Estudo clínico pragmático, do tipo piloto, randomizado com três braços paralelos, aberto em relação ao controle (hidrogel) e cego entre os dois grupos de intervenção, a saber: óxido de zinco a 20% e 25%. A população do estudo foi constituída por pacientes atendidos nos ambulatórios do Instituto Lauro de Souza Lima, portadores de úlceras de perna, que já concluíram o tratamento para a hanseníase e a amostra constituída por 12 pacientes com 36 úlceras. Como desfechos primários foram avaliadas as taxas de adesão, recrutamento e de eventos adversos. O desfecho secundário foi a avaliação da eficácia das intervenções por meio da avaliação inicial e evolução da úlcera, empregando-se a Pressure Ulcer Scale for Healing (PUSH) e a mediana da área em cm2. Resultados: Quatro participantes com 11 úlceras foram incluídos no grupo hidrogel, seis participantes com 20 úlceras no grupo do óxido de zinco 20% e dois participantes com cinco úlceras no grupo do óxido de zinco 25%. A média de idade dos pacientes foi de 61,4 anos (±8,8), a metade era do sexo masculino e a maioria possuía menos que oito anos de estudo (80,0%). As taxas de recrutamento, adesão dos participantes aos produtos indicados, aos retornos para as reavaliações e eventos adversos associados aos produtos foram, respectivamente, 44,4%, 91,7%,100% e 8,3%. Quanto à eficácia, não houve diferença entre os grupos em relação à evolução da área, entretanto, o grupo controle apresentou maior redução da escala PUSH (p<0,02). Dentre as dificuldades de aplicação do protocolo de pesquisa, destacaram-se as relacionadas ao instrumento de coleta de dados com destaque para a avaliação da área da úlcera. Tendo-se em vista a experiência de emprego do formulário de coleta de dados do estudo piloto, foi criado como produto o ebook intitulado Instrumento para desenvolvimento do Processo de Enfermagem no acompanhamento de pacientes com úlcera de perna secundária à hanseníase, que pode ser acessado no link https://drive.google.com/file/d/1HE1unzlDBmehsDADsBmRHWVxM8G9FQbT/view. Conclusão: o estudo permitiu concluir que há viabilidade de emprego do protocolo analisado, sugerindo ajustes na forma de obtenção e pontuação do escore relacionado à maior medida da área da úlcera. Devido à baixa taxa de recrutamento, deve ser considerado o desenvolvimento do estudo futuro em mais de um centro pesquisador(AU).

The chronic skin ulcers of neuropathic origin, secondary to leprosy, are difficult to heal and costly to the public health system and patients. There are high technology dressings for wound treatment, however, they are expensive. In this way, it is necessary to identify the treatment which can be applied to this population, seeking to minimize or completely reduce the ulcer at lower costs. Objective: To evaluate the viability of a protocol for the use of zinc oxide ointment at 20% and 25% concentrations compared to hydrogel, in the treatment of chronic leg ulcers of people with leprosy sequelae, and to suggest a follow-up instrument for patients under treatment of chronic ulcers. Method: This is a pragmatic, pilottype, randomized trial with three parallel segments, open to the control (hydrogel) and blind between the two intervention groups, namely: zinc oxide at 20 and 25%. The study population consisted of patients with leg ulcers, attended at the outpatient clinics of Lauro de Souza Lima Institute, who had already completed the treatment for leprosy, and the sample comprised 12 patients with 36 ulcers. Adherence, recruitment, and adverse event rates were assessed as primary outcomes. Evaluation of the efficacy of the interventions through the initial evaluation and evolution of the ulcer, using Pressure Ulcer Scale for Healing (PUSH), and median of the area in cm2, were assessed as secondary outcomes. Results: Four participants with 11 ulcers were included in the hydrogel group, six participants with 20 ulcers in the zinc oxide group at 20%, and two participants with 05 ulcers in the zinc oxide group at 25%. The mean age of the patients included in the study was 61.4 years (± 8.8); half were males and the majority had attended school for less than eight years (80.0%). The recruitment rates, adhesion of the participants to the indicated products, the returns to the reassessments and adverse events associated with the products, were, respectively, 44.4%, 91.7%, 100% and 8.3%. Concerning effectiveness, there was no difference between groups in relation to the evolution of the area, but the control group presented a greater reduction in the PUSH scale (p<0,02). Among the difficulties of applying the research protocol, the ones related to data collection instrument were predominant for ulcer evaluation. Considering the experience of using the data collection form of the pilot study, the ebook entitled Instrument for Nursing Process Development in the follow-up of leprosy leg ulcer patients was created as a product link https://drive.google.com/file/d/1HE1unzlDBmehsDADsBmRHWVxM8G9FQbT/view. Conclusion: the study led to conclude that the protocol analyzed is feasible to be applied, suggesting adjustments for obtaining and punctuating the score related to the largest measurement of the ulcer area. Due to the low recruitment rates, further studies are necessary in more than one research center(AU).

Trophic skin ulceration in leprosy: evaluation of the efficacy of topical phenytoin sodium zinc oxide paste.

BACKGROUND: The trophic or chronic plantar ulcer of leprosy is one of the principle causes of disability and deformity in the disease and has been given due importance in the evolution of its classification. In view of the diversity of its clinical implications, the World Health Organization was obliged to bring this entity under its remit in order to develop uniform guidelines to be applied around the globe. Despite relentless endeavor, its management continues to represent a dilemma. OBJECTIVES: The role of topical phenytoin sodium in wound healing led this group to evaluate its efficacy in the healing of trophic or chronic plantar ulcers. The success of the therapy was assessed according to the extent of regression in the size of the ulcer(s) following the formation of granulation tissue. METHODS: Forty patients released from leprosy control were recruited. A retrospective diagnosis was made in each case, and patients were grouped accordingly. Demographic data were recorded after the provision of informed consent. Bacterial cultures before and after treatment, and radiography were performed in each case. A phenytoin sodium fine powder zinc oxide paste dressing was applied every day for four weeks. Granulation was graded according to its appearance in order to evaluate the success of the topical therapy. RESULTS: Of the 40 patients, 26 (65.0%) borderline lepromatous leprosy patients had trophic ulcers, with the ball of the great toe being the most common site. Twelve (30.0%) patients had bone involvement. A total of 22 (55.0%) patients achieved complete resolution of the ulcer, and evidence of granulation formation was seen in 33 (82.5%) patients. The clearance of bacterial load after treatment was a significant finding. Zinc oxide paste per se was not effective, but its role as a vehicle was an asset. CONCLUSIONS: Phenytoin sodium zinc oxide paste was found to be an efficacious, cost-effective, and well-tolerated alternative therapy. Patient compliance was good. Bone involvement contributed to poor wound healing, but the clearance of bacterial load was significant.

Physical sunscreens: on the comeback trail.

Awareness of ultraviolet radiation-induced skin damage creates the need for the development of broad-spectrum, safe and cosmetically acceptable sunscreens. Being relatively inert, safe, stable and non-irritating, physical sunscreens are particularly useful for patients with sensitive skin who cannot tolerate chemical sunscreens. However, they form a thick visible pigment layer on the skin. To overcome this drawback, microfine oxides have been developed which made the sunscreens virtually transparent when applied on the skin. This article reviews the rationale for the comeback of physical sunscreens by analyzing data from various sources.

DDS-induced photosensitivity with reference to six case reports.

Photosensitivity as an adverse reaction to DDS was recognized in 6 patients of our hospital during the summer of 1988. The clinical manifestations and also the management of those patients are given in detail. All doctors and health workers involved with leprosy need to be aware of such a problem and to take correct decisions after weighing the risk of photosensitivity against the potential benefit of DDS.