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The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial
INTRODUCTION: The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating negative pressure wound therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214590/ https://www.ncbi.nlm.nih.gov/pubmed/37237316 http://dx.doi.org/10.1186/s40814-023-01308-z |
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author | Lumsden, Emma Kimble, Roy McMillan, Catherine Storey, Kristen Ware, Robert S. Griffin, Bronwyn |
author_facet | Lumsden, Emma Kimble, Roy McMillan, Catherine Storey, Kristen Ware, Robert S. Griffin, Bronwyn |
author_sort | Lumsden, Emma |
collection | PubMed |
description | INTRODUCTION: The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating negative pressure wound therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has known associated therapeutic burden; however, this burden is hypothesised to be outweighed by an increased likelihood of hypertrophic scar prevention. This study will assess the feasibility, acceptability and safety of NPWT in paediatric hand and foot burns with secondary outcomes of time to re-epithelialisation, pain, itch, cost and scar formation. METHODS AND ANALYSIS: This is a single-site, pilot randomised control trial. Participants must be aged ≤ 16 years, otherwise well and managed within 24 h of sustaining either a hand or foot burn. Thirty participants will be randomised to either standard care (Mepitel®—a silicone wound interface contact dressing—and ACTICOAT™—a nanocrystalline silver-impregnated dressing) or standard care plus NPWT. Patients will be reviewed until 3 months post-burn wound re-epithelialisation, with measurements taken at dressing changes to assess primary and secondary outcomes. Surveys, randomisation and data storage will be done via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis will be performed using the Stata statistical software. ETHICS AND DISSEMINATION: Queensland Health and Griffith University Human Research ethics approval including a site-specific assessment was obtained. The findings of this study will be disseminated through clinical meetings, conference presentations and peer reviewed journals. TRIAL REGISTRATION: Registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12622000044729, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381890&isReview=true, registered 17/01/2022). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01308-z. |
format | Online Article Text |
id | pubmed-10214590 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-102145902023-05-27 The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial Lumsden, Emma Kimble, Roy McMillan, Catherine Storey, Kristen Ware, Robert S. Griffin, Bronwyn Pilot Feasibility Stud Study Protocol INTRODUCTION: The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating negative pressure wound therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has known associated therapeutic burden; however, this burden is hypothesised to be outweighed by an increased likelihood of hypertrophic scar prevention. This study will assess the feasibility, acceptability and safety of NPWT in paediatric hand and foot burns with secondary outcomes of time to re-epithelialisation, pain, itch, cost and scar formation. METHODS AND ANALYSIS: This is a single-site, pilot randomised control trial. Participants must be aged ≤ 16 years, otherwise well and managed within 24 h of sustaining either a hand or foot burn. Thirty participants will be randomised to either standard care (Mepitel®—a silicone wound interface contact dressing—and ACTICOAT™—a nanocrystalline silver-impregnated dressing) or standard care plus NPWT. Patients will be reviewed until 3 months post-burn wound re-epithelialisation, with measurements taken at dressing changes to assess primary and secondary outcomes. Surveys, randomisation and data storage will be done via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis will be performed using the Stata statistical software. ETHICS AND DISSEMINATION: Queensland Health and Griffith University Human Research ethics approval including a site-specific assessment was obtained. The findings of this study will be disseminated through clinical meetings, conference presentations and peer reviewed journals. TRIAL REGISTRATION: Registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12622000044729, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381890&isReview=true, registered 17/01/2022). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01308-z. BioMed Central 2023-05-26 /pmc/articles/PMC10214590/ /pubmed/37237316 http://dx.doi.org/10.1186/s40814-023-01308-z Text en © Crown 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Lumsden, Emma Kimble, Roy McMillan, Catherine Storey, Kristen Ware, Robert S. Griffin, Bronwyn The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title | The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title_full | The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title_fullStr | The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title_full_unstemmed | The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title_short | The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
title_sort | feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214590/ https://www.ncbi.nlm.nih.gov/pubmed/37237316 http://dx.doi.org/10.1186/s40814-023-01308-z |
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