Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)

Detalhes bibliográficos
Autor(a) principal: Soares, Rhea Silvia de Avila
Data de Publicação: 2019
Tipo de documento: Tese
Idioma: por
Título da fonte: Manancial - Repositório Digital da UFSM
Texto Completo: http://repositorio.ufsm.br/handle/1/20713
Resumo: It is relevant to evaluate new technologies in PI prevention to substantiate a professional practice based on scientific evidences. The objective of this research is to evaluate the efficacy of multi-layered soft silicone foam dressing compared to transparent polyurethane film in heels pressure injury prevention, in patients hospitalized in intensive care unit (ICU) with high and very high risk. It was performed a within person randomized clinical trial, developed in a university hospital from south of Brazil, from July 21st 2017 to March 25th 2018. The sample consisted of successive entries of the patients that met the inclusion criteria, from daily visits the ICU for the recruitment of eligible patients, totalling 92 patients and 184 cutaneous sites. Randomization was performed for the heels: intervention group (multi-layered soft silicone foam dressing) and control group (transparent polyurethane film). After randomization and initial data collection (baseline), the intervention was performed according to each group. Data were analyzed by the program Statistical Package for Social Sciences version 21. In order to evaluate the primary outcome (PI development), the incidence and relative risk were calculated. For the variables of the skin microclimate on the first day (baseline) and the last (end), a Wilcoxon test was performed. To analyze the outcome variables between the groups with and without PI development, Student's t test or Mann-Whitney U test was performed. To verify the association between the qualitative independent variables and the development of LP, a Chi- Square or Fisher's exact test was performed. In order to analyze the correlation between the quantitative variables, Spearman's correlation was used. A level of statistical significance of 5% was used. The ethical aspects were observed according to precepts established in Resolution 466/2012 of the National Health Council. The PI incidence was 10.9%, with 8.7% in the intervention group and 13.0% in the control group. The difference in incidence between groups was not significant (p=0.333). The skin temperature of heels that developed LP as well as of heels in use of the transparent polyurethane film did not present significant difference between baseline and end. The factors associated with the PI development were age, length of stay in the study, length of hospital stay prior to ICU, edema and erythema. The study provides additional evidence to support the use of multi-layered soft silicone foam dressing in PI prevention. The relative risk was 0.67, thus those who used multi-layered soft silicone foam dressing had 33% lower risk of PI developing compared to patients using transparent polyurethane film.
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spelling Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)Efficacy of multi-layered soft silicone foam dressing compared to transparent polyurethane film in heels pressure injury prevention: within person randomized clinical trial (Pressure Injury Prevention Trial − PIPT)EnfermagemLesão por pressãoEnsaio clínicoTemperatura corporalPeleNursingPressure ulcerClinical trialBody temperatureSkinCNPQ::CIENCIAS DA SAUDE::ENFERMAGEMIt is relevant to evaluate new technologies in PI prevention to substantiate a professional practice based on scientific evidences. The objective of this research is to evaluate the efficacy of multi-layered soft silicone foam dressing compared to transparent polyurethane film in heels pressure injury prevention, in patients hospitalized in intensive care unit (ICU) with high and very high risk. It was performed a within person randomized clinical trial, developed in a university hospital from south of Brazil, from July 21st 2017 to March 25th 2018. The sample consisted of successive entries of the patients that met the inclusion criteria, from daily visits the ICU for the recruitment of eligible patients, totalling 92 patients and 184 cutaneous sites. Randomization was performed for the heels: intervention group (multi-layered soft silicone foam dressing) and control group (transparent polyurethane film). After randomization and initial data collection (baseline), the intervention was performed according to each group. Data were analyzed by the program Statistical Package for Social Sciences version 21. In order to evaluate the primary outcome (PI development), the incidence and relative risk were calculated. For the variables of the skin microclimate on the first day (baseline) and the last (end), a Wilcoxon test was performed. To analyze the outcome variables between the groups with and without PI development, Student's t test or Mann-Whitney U test was performed. To verify the association between the qualitative independent variables and the development of LP, a Chi- Square or Fisher's exact test was performed. In order to analyze the correlation between the quantitative variables, Spearman's correlation was used. A level of statistical significance of 5% was used. The ethical aspects were observed according to precepts established in Resolution 466/2012 of the National Health Council. The PI incidence was 10.9%, with 8.7% in the intervention group and 13.0% in the control group. The difference in incidence between groups was not significant (p=0.333). The skin temperature of heels that developed LP as well as of heels in use of the transparent polyurethane film did not present significant difference between baseline and end. The factors associated with the PI development were age, length of stay in the study, length of hospital stay prior to ICU, edema and erythema. The study provides additional evidence to support the use of multi-layered soft silicone foam dressing in PI prevention. The relative risk was 0.67, thus those who used multi-layered soft silicone foam dressing had 33% lower risk of PI developing compared to patients using transparent polyurethane film.É relevante avaliar novas tecnologias na prevenção das lesões por pressão para fundamentar uma práxis profissional baseada em evidências científicas. O objetivo desta pesquisa é avaliar a eficácia do uso da espuma multicamadas de poliuretano com silicone (EMPS) comparada ao filme transparente de poliuretano (FTP) na prevenção de LP em pacientes hospitalizados em unidade de tratamento intensivo (UTI) com alto risco ou risco muito alto. Trata-se de um ensaio clínico randomizado autocontrolado, desenvolvido em um hospital universitário do sul do Brasil, de julho de 2017 a março de 2018. A amostra foi constituída por entradas sucessivas dos pacientes que atenderam aos critérios de inclusão, a partir de visitas diárias a UTI para recrutamento dos pacientes elegíveis, totalizando 92 pacientes e 184 sítios cutâneos. A randomização foi realizada para os calcâneos: grupo intervenção (EMPS) e grupo controle (FTP). Após a randomização e coleta dos dados iniciais (baseline) foi realizada a intervenção de acordo com cada grupo. Os dados foram analisados pelo programa Statistical Package for Social Sciences versão 21. Para avaliar o desfecho primário (desenvolvimento de LP), foi calculada a incidência e o risco relativo. Para as variáveis do microclima da pele, foi realizado teste de Wilcoxon. Para analisar as variáveis de desfecho entre os grupos com e sem desenvolvimento de LP, realizou-se teste t de Student ou U de Mann-Whitney. Para verificar a associação entre as variáveis independentes qualitativas e o desenvolvimento de LP, foi realizado teste de Qui-Quadrado ou Exato de Fisher. A fim de analisar a correlação entre as variáveis quantitativas, utilizou-se correlação de Spearman. Foi empregado um nível de significância estatística de 5%. Os aspectos éticos foram observados conforme preceitos estabelecidos na Resolução 466/2012 do Conselho Nacional da Saúde. A incidência de LP foi de 10,9%, com 8,7% no grupo intervenção e 13,0% no grupo controle. Não foi significante a diferença na incidência entre os grupos (p=0,343). A temperatura e umidade da pele (microclima) e a oleosidade dos calcâneos sofrem alterações em seus valores quando em uso de coberturas para prevenção de lesões por pressão. A temperatura da pele dos calcâneos que desenvolveram LP, bem como dos calcâneos em uso do FTP não apresentaram diferença significativa entre baseline e end. Os fatores associados ao desenvolvimento de LP foram idade, tempo de permanência no estudo, tempo de internação anterior à UTI, edema e eritema. O estudo fornece evidências adicionais para apoiar o uso de EMPS na prevenção de LPs. O risco relativo foi de 0,67, assim quem usa a EMPS tem 33% menos risco de desenvolver LP quando comparado aos pacientes em uso do FTP.Universidade Federal de Santa MariaBrasilEnfermagemUFSMPrograma de Pós-Graduação em EnfermagemCentro de Ciências da SaúdeLima, Suzinara Beatriz Soares dehttp://lattes.cnpq.br/6711164523602200Alves, Paulo Jorge PereiraXXXXXXXXXXXXXXXXXXXXLopes, Camila Mendonça de MoraesXXXXXXXXXXXXXXXMartins, Elenice Spagnolo RodriguesXXXXXXXXXXXXXXXXXXPadoin, Stela Maris de MelloXXXXXXXXXXXXXXXMagnago, Tania Solange Bosi de SouzaXXXXXXXXXXXXXXXXXXSchwarzbold, Alexandre VargasXXXXXXXXXXXXXXXXXXXXXSoares, Rhea Silvia de Avila2021-04-28T17:42:30Z2021-04-28T17:42:30Z2019-03-25info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisapplication/pdfhttp://repositorio.ufsm.br/handle/1/20713porAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessreponame:Manancial - Repositório Digital da UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSM2021-04-29T06:02:59Zoai:repositorio.ufsm.br:1/20713Biblioteca Digital de Teses e Dissertaçõeshttps://repositorio.ufsm.br/ONGhttps://repositorio.ufsm.br/oai/requestatendimento.sib@ufsm.br||tedebc@gmail.comopendoar:2021-04-29T06:02:59Manancial - Repositório Digital da UFSM - Universidade Federal de Santa Maria (UFSM)false
dc.title.none.fl_str_mv Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
Efficacy of multi-layered soft silicone foam dressing compared to transparent polyurethane film in heels pressure injury prevention: within person randomized clinical trial (Pressure Injury Prevention Trial − PIPT)
title Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
spellingShingle Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
Soares, Rhea Silvia de Avila
Enfermagem
Lesão por pressão
Ensaio clínico
Temperatura corporal
Pele
Nursing
Pressure ulcer
Clinical trial
Body temperature
Skin
CNPQ::CIENCIAS DA SAUDE::ENFERMAGEM
title_short Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
title_full Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
title_fullStr Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
title_full_unstemmed Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
title_sort Eficácia da espuma multicamadas de poliuretano com silicone comparada ao filme transparente de poliuretano na prevenção de lesão por pressão: ensaio clínico randomizado autocontrolado (Pressure Injury Prevention Trial – PIPT)
author Soares, Rhea Silvia de Avila
author_facet Soares, Rhea Silvia de Avila
author_role author
dc.contributor.none.fl_str_mv Lima, Suzinara Beatriz Soares de
http://lattes.cnpq.br/6711164523602200
Alves, Paulo Jorge Pereira
XXXXXXXXXXXXXXXXXXXX
Lopes, Camila Mendonça de Moraes
XXXXXXXXXXXXXXX
Martins, Elenice Spagnolo Rodrigues
XXXXXXXXXXXXXXXXXX
Padoin, Stela Maris de Mello
XXXXXXXXXXXXXXX
Magnago, Tania Solange Bosi de Souza
XXXXXXXXXXXXXXXXXX
Schwarzbold, Alexandre Vargas
XXXXXXXXXXXXXXXXXXXXX
dc.contributor.author.fl_str_mv Soares, Rhea Silvia de Avila
dc.subject.por.fl_str_mv Enfermagem
Lesão por pressão
Ensaio clínico
Temperatura corporal
Pele
Nursing
Pressure ulcer
Clinical trial
Body temperature
Skin
CNPQ::CIENCIAS DA SAUDE::ENFERMAGEM
topic Enfermagem
Lesão por pressão
Ensaio clínico
Temperatura corporal
Pele
Nursing
Pressure ulcer
Clinical trial
Body temperature
Skin
CNPQ::CIENCIAS DA SAUDE::ENFERMAGEM
description It is relevant to evaluate new technologies in PI prevention to substantiate a professional practice based on scientific evidences. The objective of this research is to evaluate the efficacy of multi-layered soft silicone foam dressing compared to transparent polyurethane film in heels pressure injury prevention, in patients hospitalized in intensive care unit (ICU) with high and very high risk. It was performed a within person randomized clinical trial, developed in a university hospital from south of Brazil, from July 21st 2017 to March 25th 2018. The sample consisted of successive entries of the patients that met the inclusion criteria, from daily visits the ICU for the recruitment of eligible patients, totalling 92 patients and 184 cutaneous sites. Randomization was performed for the heels: intervention group (multi-layered soft silicone foam dressing) and control group (transparent polyurethane film). After randomization and initial data collection (baseline), the intervention was performed according to each group. Data were analyzed by the program Statistical Package for Social Sciences version 21. In order to evaluate the primary outcome (PI development), the incidence and relative risk were calculated. For the variables of the skin microclimate on the first day (baseline) and the last (end), a Wilcoxon test was performed. To analyze the outcome variables between the groups with and without PI development, Student's t test or Mann-Whitney U test was performed. To verify the association between the qualitative independent variables and the development of LP, a Chi- Square or Fisher's exact test was performed. In order to analyze the correlation between the quantitative variables, Spearman's correlation was used. A level of statistical significance of 5% was used. The ethical aspects were observed according to precepts established in Resolution 466/2012 of the National Health Council. The PI incidence was 10.9%, with 8.7% in the intervention group and 13.0% in the control group. The difference in incidence between groups was not significant (p=0.333). The skin temperature of heels that developed LP as well as of heels in use of the transparent polyurethane film did not present significant difference between baseline and end. The factors associated with the PI development were age, length of stay in the study, length of hospital stay prior to ICU, edema and erythema. The study provides additional evidence to support the use of multi-layered soft silicone foam dressing in PI prevention. The relative risk was 0.67, thus those who used multi-layered soft silicone foam dressing had 33% lower risk of PI developing compared to patients using transparent polyurethane film.
publishDate 2019
dc.date.none.fl_str_mv 2019-03-25
2021-04-28T17:42:30Z
2021-04-28T17:42:30Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/doctoralThesis
format doctoralThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://repositorio.ufsm.br/handle/1/20713
url http://repositorio.ufsm.br/handle/1/20713
dc.language.iso.fl_str_mv por
language por
dc.rights.driver.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de Santa Maria
Brasil
Enfermagem
UFSM
Programa de Pós-Graduação em Enfermagem
Centro de Ciências da Saúde
publisher.none.fl_str_mv Universidade Federal de Santa Maria
Brasil
Enfermagem
UFSM
Programa de Pós-Graduação em Enfermagem
Centro de Ciências da Saúde
dc.source.none.fl_str_mv reponame:Manancial - Repositório Digital da UFSM
instname:Universidade Federal de Santa Maria (UFSM)
instacron:UFSM
instname_str Universidade Federal de Santa Maria (UFSM)
instacron_str UFSM
institution UFSM
reponame_str Manancial - Repositório Digital da UFSM
collection Manancial - Repositório Digital da UFSM
repository.name.fl_str_mv Manancial - Repositório Digital da UFSM - Universidade Federal de Santa Maria (UFSM)
repository.mail.fl_str_mv atendimento.sib@ufsm.br||tedebc@gmail.com
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