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Bluebelle study (phase A) : a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies
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BLUEBELLE Trial (Including: Andronis, L. (Lazaros) ). (2016) Bluebelle study (phase A) : a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies. BMJ Open, 6 (9). e012635. doi:10.1136/bmjopen-2016-012635 ISSN 2044-6055.
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Official URL: http://dx.doi.org/10.1136/bmjopen-2016-012635
Abstract
Objectives Dressing primary surgical wounds is common, but the implications for surgical site infection (SSI) remain unknown. The Bluebelle study aimed to determine the feasibility of a randomised controlled trial (RCT) comparing ‘simple’, ‘complex’ or ‘no’ dressings on abdominal wounds, as prespecified in a funder's research brief. Bluebelle includes exploratory work (phase A) to inform a pilot version of the proposed RCT (phase B). Phase A aimed to investigate current dressing practices and perspectives on the proposed RCT, with a view to refining the forthcoming pilot.
Design Mixed methods, including semi-structured interviews and document analysis.
Setting 6 UK hospitals.
Participants 51 patients and 92 clinical professionals from abdominal surgical specialities.
Results Professionals had variable interpretations of what constitutes a ‘dressing’, particularly with respect to ‘glue’—a product listed under ‘wound-closure products’ in the British National Formulary, which some surgeons reportedly applied as a ‘wound covering’. Areas of ambiguity arising from interviews informed development of pragmatic definitions, including specification of conditions under which glue constituted a ‘dressing’. Professionals reported that ‘simple’ dressings were routinely used in practice, whereas ‘complex’ dressings were not. This raised questions about the relevance of comparison groups, prompting the design of a survey to determine the types/frequency of dressing use in abdominal surgery (reported elsewhere). This confirmed that complex dressings were rarely used, while ‘glue as a dressing’ was used relatively frequently. ‘Complex dressings’ were therefore substituted for ‘glue as a dressing’ (following an updated Cochrane review, which found insufficient evidence to determine the effectiveness of ‘glue as a dressing’). Patients and professionals acknowledged uncertainty around dressing use and SSI prevention, but felt dressings may serve practical and/or psychological benefits. This steered development of additional outcome measures for the pilot.
Conclusions Pre-trial qualitative research can highlight areas of ambiguity and inform new lines of enquiry in relation to prespecified research briefs, enabling adjustments to RCT design that enhance relevance to practice.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 1 February 2016 | ||||||
| Dates: |
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| Volume: | 6 | ||||||
| Number: | 9 | ||||||
| Article Number: | e012635 | ||||||
| DOI: | 10.1136/bmjopen-2016-012635 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) |
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