Effectiveness of topical treatment for pain control of malignant fungating wound in adults compared to systemic treatment: a systematic review protocol

Objective: To synthesize the evidence of the effectiveness of topical treatment compared to the systemic treatment for pain control in Malignant Fungating Wounds (MFWs) in adults. Introduction: Approximately 14.5% of cancer patients present MFWs due to the increased survival rate of oncology treatments, and 85% report pain in the wound. Previous systematic reviews on the subject have explored MFWs-related symptoms (bleeding, foul odor, and exudate) but without results concerning the pain. A recently published scoping review mapped 20 proposals for topical treatment of MFWs-related pain, originated in different studies designs. Currently, there is a need to carry out an effectiveness review in order to facilitate clinical evidence-based decision-making. Inclusion criteria: Quantitative studies on the effects of topical therapies for pain control in MFWs compared to systemic treatments in adult patients in English, Portuguese, and Spanish without any time limits. Studies that do not meet 70% of the methodological quality threshold will be excluded. Methods: A review of effectiveness according to the JBI methodology. The titles and abstracts of identified records will be checked for the inclusion criteria, and the selected papers will be reviewed in their entirety for their relevance to the objective. The selection of the studies will be carried out according to the defined threshold of the assessment of the methodological quality using the JBI Critical Appraisal Checklist instruments, and the data of interest will be extracted by two reviewers. Finally, the data synthesis will be presented in a narrative and/or statistical summary. Systematic review registration number: CRD42022351715

Topical therapy for pain management in malignant fungating wounds: a scoping review / Terapia Tópica para el manejo del dolor en heridas neoplásicas malignas: revisión de alcance / Terapia tópica para controle da dor em feridas neoplásicas malignas: revisão de escopo

Aims and objectives: To map and synthesize the existing literature on topical therapies for Malignant Fungating Wounds  pain management and the gaps involved. Background: Most cancer patients with Malignant Fungating Wounds suffer from wound-related pain, affecting their quality of life. Unfortunately, even though pain is a relevant symptom in cancer and palliative care, little is currently known about topical treatments' availability and impact on pain management. Design: A scoping review following JBI® methodology Methods: Searches were performed in CINAHL, LILACS, Embase, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR, and gray literature, in English, Portuguese and Spanish, with no time limit. Two authors independently reviewed all citations and a third was called in case of divergence, and studies in adults with Malignant Fungal Wounds reporting topical pain interventions were included. In addition, a data extraction tool for synthesis and thematic analysis was developed. This study followed the PRISMA-ScR Checklist. Results: 70 publications were selected from 796 records retrieved from databases. The studies mainly included non-systematic reviews and case studies with only six clinical trials. According to the narrative synthesis, twenty therapies were identified, including the use of wound dressings (58.6%), analgesic drugs (55.7%), topical antimicrobials (25.7%), skin barriers (15.7%), cryotherapy (5.7%), and Negative Pressure Wound Therapy (4.3%). Therapies were recommended to be applied to the wound bed or the periwound skin. In 68.5% of the studies, a standardized assessment for pain was not described.  Conclusions: Topical therapies applied to Malignant Fungating Wounds or periwound areas had been examined for pain management. However, their effectiveness was analyzed in a few interventional studies, indicating the need for further primary studies to inform evidence-based practice.  Implication for Practice: Highlighted topical therapies for clinical practice consideration are opioids, anesthetics, and antimicrobials, with positive results described in randomized clinical trials. This study did not include patients. 

Objetivos: Mapear y sintetizar la literatura existente sobre las terapias tópicas para el manejo del dolor en heridas neoplásicas malignas y los vacíos en investigación. Introducción: La mayoría de los pacientes con heridas neoplásicas malignas sienten dolor relacionado con la herida, que afecta su calidad de vida. Desafortunadamente, apesar de que el dolor es un síntoma relevante tanto en el cuidado de personas con cancer como en cuidados paliativos, poco se sabe actualmente sobre la disponibilidad de tratamientos tópicos y su impacto en el manejo del dolor. Diseño: Revisión de escopo según la metodología de la JBI®. Métodos: fueron realizada búsquedas en las bases de datos CINAHL, LILACS, Embase, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR, y literatura gris; en inglés, español y portugués, sin límite de tiempo. Dos autores revisaron todas las citaciones independientemente. Estudios en adultos con heridas neoplásicas malignas que reportaran intervenciones tópicas para el dolor fueron incluidos. Adicionalmente, un instrumento para extracción de datos fue desarrollado para la síntesis y análisis del tema. Este estudio siguió la lista de chequeo para el reporte de revisiones de alcance PRISMA-ScR de la red Equator. Resultados: 70 Publicaciones fueron seleccionadas de 796 identificadas en las bases de datos. Los estudios incluyeron principalmente revisiones no sistemáticas y estudios de caso; solo seis fueron ensayos clínicos. Según la síntesis narrativa realizada, fueron identificadas veinte terapias, que incluyeron el uso de apósitos (58.6%), drogas analgésicas (55.7%), antimicrobianos tópicos (25.7%), protectores de piel (15.7%), crioterapia (5.7%), y terapia por presión negativa (4.3%). Las diversas terapias tópicas fueron recomendadas para el el lecho de la herida y el área perilesional. En el 68.5% de los estudios, no fue descrita la aplicación de instrumentos para la valoración del dolor. Conclusiones: fueron identificadas terapias tópicas aplicadas al lecho de las heridas neoplásicas malignas o al área perilesionar, para el manejo del dolor. Sin embargo, la efectividad de las intervenciones fue analizada por pocos estudios clínicos, indicando la necesidad por más estudios primarios que informen la prácica clínica basada en la evidencia. Implicaciones para la práctica: se destacan para aplicación clínica, el uso de opioides, anestésicos y antimicrobianos, con resultados positivos en ensayos clínicos randomizados. Este estudio no incluyó pacientes. 

Objetivos: Mapear e sintetizar a literatura existente sobre terapias tópicas para o manejo da dor em feridas neoplásicas malignas e as lacunas de pesquisa. Introdução: A maioria dos pacientes com feridas neoplásicas malignas sente dor relacionada à ferida, o que afeta sua qualidade de vida. Infelizmente, apesar da dor ser um sintoma relevante tanto no tratamento oncológico quanto nos cuidados paliativos, pouco se sabe atualmente sobre a disponibilidade de tratamentos tópicos e seu impacto no controle da dor. Desenho: Revisão do escopo de acordo com a metodologia JBI®. Métodos: CINAHL, LILACS, Embase, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR e bases de dados de literatura cinzenta foram pesquisados; em inglês, espanhol e português, sem limite de tempo. Dois autores revisaram todas as citações de forma independente. Estudos em adultos com feridas neoplásicas malignas relatando intervenções tópicas para dor foram incluídos. Adicionalmente, foi desenvolvido um instrumento de extração de dados para a síntese e análise do tema. Este estudo seguiu a lista de verificação do relatório de revisão de escopo PRISMA-ScR da rede Equator. Resultados: Foram selecionadas 70 publicações dentre 796 identificadas nas bases de dados. Os estudos incluíram principalmente revisões não sistemáticas e estudos de caso; apenas seis eram ensaios clínicos. De acordo com a síntese narrativa realizada, foram identificadas vinte terapias, que incluíram o uso de curativos (58,6%), analgésicos (55,7%), antimicrobianos tópicos (25,7%), protetores cutâneos (15,7%), crioterapia (5,7%). , e terapia com pressão negativa (4,3%). Várias terapias tópicas foram recomendadas para o leito da ferida e a área periferida. Em 68,5% dos estudos não foi descrita a aplicação de instrumentos para avaliação da dor. Conclusões: foram identificadas terapias tópicas aplicadas no leito de feridas neoplásicas malignas ou na área perilesional, para controle da dor. No entanto, a eficácia das intervenções foi analisada por poucos estudos clínicos, indicando a necessidade de mais estudos primários que informem a prática clínica baseada em evidências. Implicações para a prática: o uso de opioides, anestésicos e antimicrobianos se destaca pela aplicação clínica, com resultados positivos em ensaios clínicos randomizados. Este estudo não incluiu pacientes.

Terapia tópica para el tratamiento del dolor en heridas neoplásicas malignas: protocolo de revisión de alcance.

BACKGROUND: A total of 14.5% of cancer patients develop malignant neoplastic wounds (MNW), characterised as friable, exudative, fetid, bleeding, and painful. Some studies report that all patients with MNW experience pain, but there is lack of scientific evidence to support their treatment. OBJECTIVE: To map and examine the existing evidence on topical therapies to manage pain in adult patients with MNW. METHOD: A scoping review protocol was designed, according to the Joanna Briggs Institute (JBI) methodology. The databases CINAHL, LILACS, Embase, Scopus, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR and the grey literature, for searching published and unpublished studies in English, Portuguese and Spanish. The selection will be made by at least two reviewers. The summary of the results will be narrative, with graphs and tables. Qualitative and quantitative studies and reviews will be included, describing the use of topical pain therapies in patients with MNW. CONCLUSION: This study will allow to classify and discuss the available topical therapies, and to recommend future primary studies.

INTRODUCCIÓN: El 14,5% de los pacientes con cáncer desarrolla heridas neoplásicas malignas (HNM), caracterizadas como friables, exudativas, fétidas, sangrantes y dolorosas. Algunos estudios reportan que todos los pacientes con HNM experimentan dolor, pero hay escasez de evidencia científica para fundamentar su tratamiento. OBJETIVO: Mapear y examinar la evidencia existente sobre terapias tópicas para manejar el dolor en pacientes adultos con HNM. MÉTODO: Se diseñó un protocolo de revisión de alcance, de acuerdo con la metodología del Joanna Briggs Institute (JBI). Serán consultadas las bases de datos CINAHL, LILACS, Embase, Scopus, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR y la literatura gris, para la búsqueda de estudios publicados y no publicados en inglés, portugués y español. La selección estará a cargo de, al menos, dos revisores. La síntesis de los resultados será narrativa, con gráficos y tablas. Se incluirán estudios cualitativos, cuantitativos y revisiones, que describan el uso de terapias tópicas para el dolor en pacientes con HNM. CONCLUSIÓN: Este estudio permitirá clasificar y discutir las terapias tópicas disponibles, y recomendar futuros estudios primarios.

Malignant Wounds in Hospitalized Oncology Patients: Prevalence, Characteristics, and Associated Factors.

Epidemiological and descriptive research on malignant wounds (MWs) is scarce. The objective of this study was to identify the prevalence of MWs and analyze the characteristics and associated factors of MWs in hospitalized patients at an oncological institution. An epidemiological, cross-sectional, and descriptive study, which was derived from a larger study that collected data on the prevalence of different types of wounds in 341 adults hospitalized in a large oncological hospital, was conducted. The present study comprehensively analyzed data related to MWs. Information was obtained through participant interviews, physical examination, and medical record review. The study was approved by the ethics committee of the institution where the study was conducted. Fourteen MWs were identified in 13 patients, who were primarily married (58%) and men (75%), with a mean age of 60.5 ± 15.1 years. Malignant wounds were predominantly located in the head and neck region (43%) and classified as 1N (50%) according to the Staging of Malignant Cutaneous Wounds instrument. Malignant wounds were characterized as painful (83.3%), with significant pain present during dressing changes (93%). The presence of MWs was associated with the use of antidepressants (odds ratio [OR] = 4.95; p = .012), upper-limb edema (OR = 8.39; p = .003), and infection (OR = 12.16; p = .051). The prevalence of MWs in hospitalized patients was 3.8%. Associated clinical variables were related to the degree of disease progression. This information provides evidence of the need for research identifying and investigating nursing interventions for patients with MW to assist with pain control during dressing changes.

Terapia tópica para controle da dor em ferida neoplásica maligna: revisão de escopo / Topical therapy for pain management of malignant fungating wounds: a scoping review protocol

Introdução: Pacientes com câncer, principalmente de mama e cabeça e pescoço, podem desenvolver feridas neoplásicas malignas (FNM) como uma importante complicação. As FNM são lesões friáveis, exsudativas, fétidas e dolorosas que impactam negativamente na qualidade de vida das pessoas. Estudos mostram que todos os pacientes com FNM apresentam dor nessas lesões, a maioria com intensidade moderada a grave. A literatura tem estabelecido recomendações para o cuidado de pacientes com FNM visando ao gerenciamento ou controle dos sintomas porém embasadas em escassas evidências. Objetivo: Examinar e mapear e as evidências existentes sobre as terapias tópicas utilizadas para o controle da dor em FNM. Métodos: Revisão de escopo, conduzida de acordo com a metodologia do Joanna Briggs Institute (JBI). Foram pesquisadas as publicações nos bancos de dados CINAHL, LILACS, Embase, Scopus, Web of science e PubMed, Cochrane, NICE, Scopus, JBISRIR e literatura cinzenta, em inglês, português e espanhol e sem delimitação de tempo. Esta revisão considerou estudos realizados com pacientes, a partir de 18 anos de idade, com dor em FNM. A busca foi realizada em três etapas. Após as buscas, todos os registros identificados foram agrupados e enviados para Mendeley (MendeleyLtd., Elsevier, Holanda). Os títulos e resumos foram examinados por dois revisores independentes. Os dados foram extraídos usando uma ferramenta de extração de dados desenvolvida pelos revisores. Após a extração dos dados, realizou-se uma reunião entre os revisores para a análise dos dados e organização das categorias que deles emergiram. Resultados: Incluíram-se 70 publicações compostas por 32 Revisões não Sistemáticas de Literatura - RNS, 20 Estudos de casos - EC, seis Ensaios Clínicos Randomizados - ECR, três Coortes Retrospectivas - CP, três Revisões Sistemáticas - RS, três Guidelines, dois Surveys e uma Coorte Retrospectiva - CR que evidenciaram 20 propostas de terapias tópicas para controle de dor em FNM, assim categorizadas: Terapias Tópicas Aplicadas nas FNM (Coberturas (41 / 58,6%), Drogas analgésicas (39 / 55,7%), Substâncias antimicrobianas (18 / 25,7%), Crioterapia (4 / 5,7%) e Terapia por Pressão Negativa (3 / 4,3%) e Terapias Tópicas aplicadas na Pele Peri-Ferida (Protetores de pele (11 / 15,7%)). A dor não foi avaliada em 68,5% dos estudos. Conclusão: Muitas são as terapias tópicas descritas nesta revisão de escopo (70 publicações incluídas) para o controle de dor em FNM, principalmente do tipo RNS (32/ 45,7%) e mesmo EC (20/ 28,5%). No entanto, existem poucos estudos primários de intervenção voltados especificamente para a avaliação da sua eficácia, com metodologias consideradas inadequadas para sustentar a prática clínica, evidenciando a necessidade de novos estudos com delineamentos mais robustos. Implicações para a prática clínica e pesquisa: Esta revisão de escopo contribui para a sistematização dos achados acerca do controle da dor em FNM, sintoma bastante frequente na plêiade que acompanha essa condição tão impactante sobre a qualidade de vida e final de vida dos pacientes por ela acometidos. Seus resultados certamente possibilitam a implementação mais adequada de atenção multiprofissional a esses pacientes bem como mostram as lacunas de investigação para suporte a uma prática mais segura.

Introduction: Cancer patients, especially breast and head and neck, can develop malignant fungating wounds (MFW) as an important complication. MFW are friable, exudative, fetid, and painful lesions that negatively impact people\'s quality of life. Studies show that all patients with MFW have pain in these lesions, the majority with moderate to severe intensity. The literature has established recommendations for the care of patients with MFW aiming at the management or control of symptoms but based on little evidence. Objective: Examine and map and the existing evidence on topical therapies used to control pain in NFM. Methods: Scoping review, conducted according to the Joanna Briggs Institute (JBI) methodology. Publications were searched in the CINAHL, LILACS, Embase, Scopus, Web of Science and PubMed, Cochrane, NICE, Scopus, JBISRIR, and gray literature databases in English, Portuguese and Spanish and without time limits. This review considered studies carried out with patients, from 18 years of age, with pain in NMF. The search was carried out in three stages. After the searches, all identified records were grouped and sent to Mendeley (MendeleyLtd., Elsevier, Netherlands). Titles and abstracts were examined by two independent reviewers. The data were extracted using a data extraction tool developed by the reviewers. After extracting the data, a meeting was held between the reviewers to analyze the data and organize the categories that emerged from them. Results: 70 publications comprising 32 non-systematic literature reviews - RNS, 20 case studies - EC, six randomized clinical trials - ECR, three retrospective cohorts - CP, three systematic reviews - RS, three guidelines, two Surveys, and a Retrospective Cohort - CR that showed 20 proposals for topical therapies for pain control in FNM, categorized as follows: Topical Therapies Applied in MFW (Dressing (41 / 58.6%), Analgesic Drugs (39 / 55.7%), Substances antimicrobials (18 / 25.7%), Cryotherapy (4 / 5.7%) and Negative Pressure Therapy (3 / 4.3%) and Topical Therapies applied to Peri-Wound Skin (Skin Protectors (11/15, 7%)). Pain has not been evaluated in 68.5% of the studies. Conclusion: There are many topical therapies described in this scoping review (70 publications included) for pain control in NFM, mainly of the RNS type (32 / 45.7%) and even EC (20 / 28.5%). However, there are few primary studies interventions aimed specifically at assessing their effectiveness, with methodologies considered inadequate to support clinical practice, highlighting the need for further studies with more robust designs. Implications for clinical practice and research: This scoping review contributes to the systematization of the findings of pain control in MFW, a very common symptom in the crowd that accompanies this condition that has such an impact on the quality of life and end of life of patients through it affected. Its results certainly enable the most appropriate implementation of multi-professional care for these patients, as well as showing the research gaps to support a safer practice.