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A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial
BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibili...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576037/ https://www.ncbi.nlm.nih.gov/pubmed/28851399 http://dx.doi.org/10.1186/s13063-017-2102-5 |
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author | Reeves, Barnaby C. Andronis, Lazaros Blazeby, Jane M. Blencowe, Natalie S. Calvert, Melanie Coast, Joanna Draycott, Tim Donovan, Jenny L. Gooberman-Hill, Rachael Longman, Robert J. Magill, Laura Mathers, Jonathan M. Pinkney, Thomas D. Rogers, Chris A. Rooshenas, Leila Torrance, Andrew Welton, Nicky J. Woodward, Mark Ashton, Kate Bera, Katarzyna D. Clayton, Gemma L. Culliford, Lucy A. Dumville, Jo C. Elliott, Daisy Ellis, Lucy Gould-Brown, Hannah Macefield, Rhiannon C. McMullan, Christel Pope, Caroline Siassakos, Dimitrios Strong, Sean Talbot, Helen |
author_facet | Reeves, Barnaby C. Andronis, Lazaros Blazeby, Jane M. Blencowe, Natalie S. Calvert, Melanie Coast, Joanna Draycott, Tim Donovan, Jenny L. Gooberman-Hill, Rachael Longman, Robert J. Magill, Laura Mathers, Jonathan M. Pinkney, Thomas D. Rogers, Chris A. Rooshenas, Leila Torrance, Andrew Welton, Nicky J. Woodward, Mark Ashton, Kate Bera, Katarzyna D. Clayton, Gemma L. Culliford, Lucy A. Dumville, Jo C. Elliott, Daisy Ellis, Lucy Gould-Brown, Hannah Macefield, Rhiannon C. McMullan, Christel Pope, Caroline Siassakos, Dimitrios Strong, Sean Talbot, Helen |
collection | PubMed |
description | BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients’ wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4–8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial. DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed. TRIAL REGISTRATION: ISRCTN49328913. Registered on 20 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2102-5) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5576037 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-55760372017-08-30 A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial Reeves, Barnaby C. Andronis, Lazaros Blazeby, Jane M. Blencowe, Natalie S. Calvert, Melanie Coast, Joanna Draycott, Tim Donovan, Jenny L. Gooberman-Hill, Rachael Longman, Robert J. Magill, Laura Mathers, Jonathan M. Pinkney, Thomas D. Rogers, Chris A. Rooshenas, Leila Torrance, Andrew Welton, Nicky J. Woodward, Mark Ashton, Kate Bera, Katarzyna D. Clayton, Gemma L. Culliford, Lucy A. Dumville, Jo C. Elliott, Daisy Ellis, Lucy Gould-Brown, Hannah Macefield, Rhiannon C. McMullan, Christel Pope, Caroline Siassakos, Dimitrios Strong, Sean Talbot, Helen Trials Study Protocol BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients’ wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4–8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial. DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed. TRIAL REGISTRATION: ISRCTN49328913. Registered on 20 October 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2102-5) contains supplementary material, which is available to authorized users. BioMed Central 2017-08-29 /pmc/articles/PMC5576037/ /pubmed/28851399 http://dx.doi.org/10.1186/s13063-017-2102-5 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Reeves, Barnaby C. Andronis, Lazaros Blazeby, Jane M. Blencowe, Natalie S. Calvert, Melanie Coast, Joanna Draycott, Tim Donovan, Jenny L. Gooberman-Hill, Rachael Longman, Robert J. Magill, Laura Mathers, Jonathan M. Pinkney, Thomas D. Rogers, Chris A. Rooshenas, Leila Torrance, Andrew Welton, Nicky J. Woodward, Mark Ashton, Kate Bera, Katarzyna D. Clayton, Gemma L. Culliford, Lucy A. Dumville, Jo C. Elliott, Daisy Ellis, Lucy Gould-Brown, Hannah Macefield, Rhiannon C. McMullan, Christel Pope, Caroline Siassakos, Dimitrios Strong, Sean Talbot, Helen A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title | A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title_full | A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title_fullStr | A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title_full_unstemmed | A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title_short | A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial |
title_sort | mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (bluebelle phase b): study protocol for a randomised controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576037/ https://www.ncbi.nlm.nih.gov/pubmed/28851399 http://dx.doi.org/10.1186/s13063-017-2102-5 |
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