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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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Bluebelle Study Group (Including:
). (2017) 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. Trials, 18 (1). 401. doi:10.1186/s13063-017-2102-5 ISSN 1745-6215.
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WRAP-mixed-methods-pragmatic-surgical-dressing-Andronis-2017.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1433Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-017-2102-5
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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | R Medicine > RD Surgery | ||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Surgical wound infections, Surgical dressings, Clinical trials | ||||||||||||
| Journal or Publication Title: | Trials | ||||||||||||
| Publisher: | Biomed Central | ||||||||||||
| ISSN: | 1745-6215 | ||||||||||||
| Official Date: | 29 August 2017 | ||||||||||||
| Dates: |
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| Volume: | 18 | ||||||||||||
| Number: | 1 | ||||||||||||
| Article Number: | 401 | ||||||||||||
| DOI: | 10.1186/s13063-017-2102-5 | ||||||||||||
| Status: | Peer Reviewed | ||||||||||||
| Publication Status: | Published | ||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
| Date of first compliant deposit: | 23 October 2017 | ||||||||||||
| Date of first compliant Open Access: | 23 October 2017 | ||||||||||||
| Funder: | National Institute for Health Research Health Technology Assessment (Great Britain) (NIHR HTA), Medical Research Council (Great Britain) (MRC), British Heart Foundation | ||||||||||||
| Grant number: | project reference 12/200/04 (NIHR HTA), Collaboration and iNnovation for DifficUlt and Complex randomised controlled Trials In Invasive procedures - MR/K025643/1 (MRC) | ||||||||||||
| RIOXX Funder/Project Grant: |
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