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 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. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Reeves, Barnaby C. [verfasserIn] 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

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Pilot study Feasibility study Randomised controlled trial Wound dressing Abdominal surgery Caesarean section Surgical site infection

Anmerkung:	© The Author(s). 2017

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 18(2017), 1 vom: 29. Aug.
Übergeordnetes Werk:	volume:18 ; year:2017 ; number:1 ; day:29 ; month:08

Links:	Volltext

DOI / URN:	10.1186/s13063-017-2102-5

Katalog-ID:	SPR030096723

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520			\|a 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.
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allfields	10.1186/s13063-017-2102-5 doi (DE-627)SPR030096723 (SPR)s13063-017-2102-5-e DE-627 ger DE-627 rakwb eng Reeves, Barnaby C. verfasserin aut 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 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213 Andronis, Lazaros aut Blazeby, Jane M. aut Blencowe, Natalie S. aut Calvert, Melanie aut Coast, Joanna aut Draycott, Tim aut Donovan, Jenny L. aut Gooberman-Hill, Rachael aut Longman, Robert J. aut Magill, Laura aut Mathers, Jonathan M. aut Pinkney, Thomas D. aut Rogers, Chris A. aut Rooshenas, Leila aut Torrance, Andrew aut Welton, Nicky J. aut Woodward, Mark aut Ashton, Kate aut Bera, Katarzyna D. aut Clayton, Gemma L. aut Culliford, Lucy A. aut Dumville, Jo C. aut Elliott, Daisy aut Ellis, Lucy aut Gould-Brown, Hannah aut Macefield, Rhiannon C. aut McMullan, Christel aut Pope, Caroline aut Siassakos, Dimitrios aut Strong, Sean aut Talbot, Helen aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 29. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:29 month:08 https://dx.doi.org/10.1186/s13063-017-2102-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 29 08
spelling	10.1186/s13063-017-2102-5 doi (DE-627)SPR030096723 (SPR)s13063-017-2102-5-e DE-627 ger DE-627 rakwb eng Reeves, Barnaby C. verfasserin aut 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 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213 Andronis, Lazaros aut Blazeby, Jane M. aut Blencowe, Natalie S. aut Calvert, Melanie aut Coast, Joanna aut Draycott, Tim aut Donovan, Jenny L. aut Gooberman-Hill, Rachael aut Longman, Robert J. aut Magill, Laura aut Mathers, Jonathan M. aut Pinkney, Thomas D. aut Rogers, Chris A. aut Rooshenas, Leila aut Torrance, Andrew aut Welton, Nicky J. aut Woodward, Mark aut Ashton, Kate aut Bera, Katarzyna D. aut Clayton, Gemma L. aut Culliford, Lucy A. aut Dumville, Jo C. aut Elliott, Daisy aut Ellis, Lucy aut Gould-Brown, Hannah aut Macefield, Rhiannon C. aut McMullan, Christel aut Pope, Caroline aut Siassakos, Dimitrios aut Strong, Sean aut Talbot, Helen aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 29. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:29 month:08 https://dx.doi.org/10.1186/s13063-017-2102-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 29 08
allfields_unstemmed	10.1186/s13063-017-2102-5 doi (DE-627)SPR030096723 (SPR)s13063-017-2102-5-e DE-627 ger DE-627 rakwb eng Reeves, Barnaby C. verfasserin aut 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 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213 Andronis, Lazaros aut Blazeby, Jane M. aut Blencowe, Natalie S. aut Calvert, Melanie aut Coast, Joanna aut Draycott, Tim aut Donovan, Jenny L. aut Gooberman-Hill, Rachael aut Longman, Robert J. aut Magill, Laura aut Mathers, Jonathan M. aut Pinkney, Thomas D. aut Rogers, Chris A. aut Rooshenas, Leila aut Torrance, Andrew aut Welton, Nicky J. aut Woodward, Mark aut Ashton, Kate aut Bera, Katarzyna D. aut Clayton, Gemma L. aut Culliford, Lucy A. aut Dumville, Jo C. aut Elliott, Daisy aut Ellis, Lucy aut Gould-Brown, Hannah aut Macefield, Rhiannon C. aut McMullan, Christel aut Pope, Caroline aut Siassakos, Dimitrios aut Strong, Sean aut Talbot, Helen aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 29. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:29 month:08 https://dx.doi.org/10.1186/s13063-017-2102-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 29 08
allfieldsGer	10.1186/s13063-017-2102-5 doi (DE-627)SPR030096723 (SPR)s13063-017-2102-5-e DE-627 ger DE-627 rakwb eng Reeves, Barnaby C. verfasserin aut 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 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213 Andronis, Lazaros aut Blazeby, Jane M. aut Blencowe, Natalie S. aut Calvert, Melanie aut Coast, Joanna aut Draycott, Tim aut Donovan, Jenny L. aut Gooberman-Hill, Rachael aut Longman, Robert J. aut Magill, Laura aut Mathers, Jonathan M. aut Pinkney, Thomas D. aut Rogers, Chris A. aut Rooshenas, Leila aut Torrance, Andrew aut Welton, Nicky J. aut Woodward, Mark aut Ashton, Kate aut Bera, Katarzyna D. aut Clayton, Gemma L. aut Culliford, Lucy A. aut Dumville, Jo C. aut Elliott, Daisy aut Ellis, Lucy aut Gould-Brown, Hannah aut Macefield, Rhiannon C. aut McMullan, Christel aut Pope, Caroline aut Siassakos, Dimitrios aut Strong, Sean aut Talbot, Helen aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 29. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:29 month:08 https://dx.doi.org/10.1186/s13063-017-2102-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 29 08
allfieldsSound	10.1186/s13063-017-2102-5 doi (DE-627)SPR030096723 (SPR)s13063-017-2102-5-e DE-627 ger DE-627 rakwb eng Reeves, Barnaby C. verfasserin aut 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 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213 Andronis, Lazaros aut Blazeby, Jane M. aut Blencowe, Natalie S. aut Calvert, Melanie aut Coast, Joanna aut Draycott, Tim aut Donovan, Jenny L. aut Gooberman-Hill, Rachael aut Longman, Robert J. aut Magill, Laura aut Mathers, Jonathan M. aut Pinkney, Thomas D. aut Rogers, Chris A. aut Rooshenas, Leila aut Torrance, Andrew aut Welton, Nicky J. aut Woodward, Mark aut Ashton, Kate aut Bera, Katarzyna D. aut Clayton, Gemma L. aut Culliford, Lucy A. aut Dumville, Jo C. aut Elliott, Daisy aut Ellis, Lucy aut Gould-Brown, Hannah aut Macefield, Rhiannon C. aut McMullan, Christel aut Pope, Caroline aut Siassakos, Dimitrios aut Strong, Sean aut Talbot, Helen aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 29. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:29 month:08 https://dx.doi.org/10.1186/s13063-017-2102-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 29 08
language	English
source	Enthalten in Trials 18(2017), 1 vom: 29. Aug. volume:18 year:2017 number:1 day:29 month:08
sourceStr	Enthalten in Trials 18(2017), 1 vom: 29. Aug. volume:18 year:2017 number:1 day:29 month:08
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Pilot study Feasibility study Randomised controlled trial Wound dressing Abdominal surgery Caesarean section Surgical site infection
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Reeves, Barnaby C. @@aut@@ Andronis, Lazaros @@aut@@ Blazeby, Jane M. @@aut@@ Blencowe, Natalie S. @@aut@@ Calvert, Melanie @@aut@@ Coast, Joanna @@aut@@ Draycott, Tim @@aut@@ Donovan, Jenny L. @@aut@@ Gooberman-Hill, Rachael @@aut@@ Longman, Robert J. @@aut@@ Magill, Laura @@aut@@ Mathers, Jonathan M. @@aut@@ Pinkney, Thomas D. @@aut@@ Rogers, Chris A. @@aut@@ Rooshenas, Leila @@aut@@ Torrance, Andrew @@aut@@ Welton, Nicky J. @@aut@@ Woodward, Mark @@aut@@ Ashton, Kate @@aut@@ Bera, Katarzyna D. @@aut@@ Clayton, Gemma L. @@aut@@ Culliford, Lucy A. @@aut@@ Dumville, Jo C. @@aut@@ Elliott, Daisy @@aut@@ Ellis, Lucy @@aut@@ Gould-Brown, Hannah @@aut@@ Macefield, Rhiannon C. @@aut@@ McMullan, Christel @@aut@@ Pope, Caroline @@aut@@ Siassakos, Dimitrios @@aut@@ Strong, Sean @@aut@@ Talbot, Helen @@aut@@
publishDateDaySort_date	2017-08-29T00:00:00Z
hierarchy_top_id	326173552
id	SPR030096723
language_de	englisch
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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. 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author	Reeves, Barnaby C.
spellingShingle	Reeves, Barnaby C. misc Pilot study misc Feasibility study misc Randomised controlled trial misc Wound dressing misc Abdominal surgery misc Caesarean section misc Surgical site infection 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
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topic_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 Pilot study (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Wound dressing (dpeaa)DE-He213 Abdominal surgery (dpeaa)DE-He213 Caesarean section (dpeaa)DE-He213 Surgical site infection (dpeaa)DE-He213
topic	misc Pilot study misc Feasibility study misc Randomised controlled trial misc Wound dressing misc Abdominal surgery misc Caesarean section misc Surgical site infection
topic_unstemmed	misc Pilot study misc Feasibility study misc Randomised controlled trial misc Wound dressing misc Abdominal surgery misc Caesarean section misc Surgical site infection
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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
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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
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author_browse	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
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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
title_auth	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
abstract	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. © The Author(s). 2017
abstractGer	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. © The Author(s). 2017
abstract_unstemmed	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. © The Author(s). 2017
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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
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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. 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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

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