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)
Autor(a) principal: | |
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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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2021-04-28T17:42:30Z2021-04-28T17:42:30Z2019-03-25http://repositorio.ufsm.br/handle/1/20713It 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.porUniversidade Federal de Santa MariaCentro de Ciências da SaúdePrograma de Pós-Graduação em EnfermagemUFSMBrasilEnfermagemAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessEnfermagemLesão por pressãoEnsaio clínicoTemperatura corporalPeleNursingPressure ulcerClinical trialBody temperatureSkinCNPQ::CIENCIAS DA SAUDE::ENFERMAGEMEficácia 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)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisLima, 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 VargasXXXXXXXXXXXXXXXXXXXXXhttp://lattes.cnpq.br/7766499332487272Soares, Rhea Silvia de Avila4004000000006009ec774b8-8966-4092-aae8-380eaeddbedc0d3d20e4-3864-4069-8926-757823008833d1d85545-0cfa-49b1-924d-6477b878db74a9eddf23-f655-41d4-8303-f9ba0165941e4d86ff6d-0493-4bf1-9705-b607fd31b67a71fa300c-80e9-4add-b24d-40a3e4822e0e30f7c52a-56b8-4dcf-b3b1-93f191054b0d3cf6db2f-5d39-4cf1-816a-b002a475e272reponame:Manancial - Repositório Digital da UFSMinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMORIGINALTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdfTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdfTese de Doutoradoapplication/pdf2161118http://repositorio.ufsm.br/bitstream/1/20713/1/TES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf3f38fedebed936dfc64d9a80d8376bbbMD51CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805http://repositorio.ufsm.br/bitstream/1/20713/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-816http://repositorio.ufsm.br/bitstream/1/20713/3/license.txtf8fcb28efb1c8cf0dc096bec902bf4c4MD53TEXTTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.txtTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.txtExtracted texttext/plain344234http://repositorio.ufsm.br/bitstream/1/20713/4/TES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.txt6281458236501e917b4fbd3cebe26889MD54THUMBNAILTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.jpgTES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.jpgIM Thumbnailimage/jpeg4569http://repositorio.ufsm.br/bitstream/1/20713/5/TES_PPGENFERMAGEM_2019_SOARES_RHEA.pdf.jpg2b9b2b548e9a32b8d3e7f09076afd387MD551/207132021-04-29 03:02:59.738oai:repositorio.ufsm.br:1/20713Q3JlYXRpdmUgQ29tbW9ucw==Repositório Institucionalhttp://repositorio.ufsm.br/PUBhttp://repositorio.ufsm.br/oai/requestopendoar:39132021-04-29T06:02:59Manancial - Repositório Digital da UFSM - Universidade Federal de Santa Maria (UFSM)false |
dc.title.por.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) |
dc.title.alternative.eng.fl_str_mv |
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.advisor1.fl_str_mv |
Lima, Suzinara Beatriz Soares de |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/6711164523602200 |
dc.contributor.advisor-co1.fl_str_mv |
Alves, Paulo Jorge Pereira |
dc.contributor.advisor-co1Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXXXX |
dc.contributor.referee1.fl_str_mv |
Lopes, Camila Mendonça de Moraes |
dc.contributor.referee1Lattes.fl_str_mv |
XXXXXXXXXXXXXXX |
dc.contributor.referee2.fl_str_mv |
Martins, Elenice Spagnolo Rodrigues |
dc.contributor.referee2Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXX |
dc.contributor.referee3.fl_str_mv |
Padoin, Stela Maris de Mello |
dc.contributor.referee3Lattes.fl_str_mv |
XXXXXXXXXXXXXXX |
dc.contributor.referee4.fl_str_mv |
Magnago, Tania Solange Bosi de Souza |
dc.contributor.referee4Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXX |
dc.contributor.referee5.fl_str_mv |
Schwarzbold, Alexandre Vargas |
dc.contributor.referee5Lattes.fl_str_mv |
XXXXXXXXXXXXXXXXXXXXX |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/7766499332487272 |
dc.contributor.author.fl_str_mv |
Soares, Rhea Silvia de Avila |
contributor_str_mv |
Lima, Suzinara Beatriz Soares de Alves, Paulo Jorge Pereira Lopes, Camila Mendonça de Moraes Martins, Elenice Spagnolo Rodrigues Padoin, Stela Maris de Mello Magnago, Tania Solange Bosi de Souza Schwarzbold, Alexandre Vargas |
dc.subject.por.fl_str_mv |
Enfermagem Lesão por pressão Ensaio clínico Temperatura corporal Pele |
topic |
Enfermagem Lesão por pressão Ensaio clínico Temperatura corporal Pele Nursing Pressure ulcer Clinical trial Body temperature Skin CNPQ::CIENCIAS DA SAUDE::ENFERMAGEM |
dc.subject.eng.fl_str_mv |
Nursing Pressure ulcer Clinical trial Body temperature Skin |
dc.subject.cnpq.fl_str_mv |
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.issued.fl_str_mv |
2019-03-25 |
dc.date.accessioned.fl_str_mv |
2021-04-28T17:42:30Z |
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2021-04-28T17:42:30Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/doctoralThesis |
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doctoralThesis |
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http://repositorio.ufsm.br/handle/1/20713 |
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por |
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400400000000 |
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Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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Universidade Federal de Santa Maria Centro de Ciências da Saúde |
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Programa de Pós-Graduação em Enfermagem |
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UFSM |
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Brasil |
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Enfermagem |
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Universidade Federal de Santa Maria Centro de Ciências da Saúde |
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