Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies. Issue 9 (22nd September 2016)

• Record Type: Journal Article
• Other Names: author non-byline.; Andronis Lazaros author non-byline.; Blazeby Jane author non-byline.; Blencowe Natalie author non-byline.; Calvert Melanie author non-byline.; Coast Joanna author non-byline.; Draycott Tim author non-byline.; Donovan Jenny L author non-byline.; Gooberman-Hill Rachael author non-byline.; Longman Robert author non-byline.; Magill Laura author non-byline.; Mathers Jonathan author non-byline.; Pinkney Tom author non-byline.; Reeves Barney author non-byline.; Rogers Chris A author non-byline.; Torrance Andrew author non-byline.; Young Trudie author non-byline.; Woodward Mark author non-byline.; Bamford Richard author non-byline.; Clayton Gemma author non-byline.; Dumville Jo author non-byline.; Elliott Daisy author non-byline.; Ellis Lucy author non-byline.; Griffiths Shelley author non-byline.; Hurley Katrina author non-byline.; Macefield Rhiannon author non-byline.; McMullan Christel author non-byline.; Main Barry author non-byline.; Milne Thomas author non-byline.; van der Nelson Helen author non-byline.; Nicholson Alexandra author non-byline.; Rooshenas Leila author non-byline.; Siassakos Dimitrios author non-byline.; Strong Sean author non-byline.; Talbot Helen author non-byline.; Winter Cathy author non-byline.; Atherton G author non-byline.; Tafazal H author non-byline.; Eriksson A author non-byline.; Chapman T author non-byline.; Zafar Z author non-byline.; Chang J author non-byline.; Sharma E author non-byline.; Green N author non-byline.; Shariff U author non-byline.; Neito T author non-byline.; Youssef H author non-byline.; Marriott P author non-byline.; Popplewell M author non-byline.; Ring N author non-byline.; Sharples A author non-byline.; Summerour V author non-byline.; Bhangu A author non-byline.; Upchurch E author non-byline.; Hardy T author non-byline.; de Barros J Monteiro author non-byline.; Reza L author non-byline.; Ekere C author non-byline.; Greenwood A author non-byline.; Strong S author non-byline.; Florance C author non-byline.; Orchard P author non-byline.; Court E author non-byline.; Ives C author non-byline.; Papworth E author non-byline.; Lee C author non-byline.; Buchan S author non-byline.; Bennett J author non-byline.; Rowlands C author non-byline.; Frank L author non-byline.; Ide K-A author non-byline.; Noble E author non-byline.; Sellars H author non-byline.; Anderson E author non-byline.; Fallaize R author non-byline.; Kynaston J author non-byline.; Hotton E author non-byline.; Banks J author non-byline.; Thompson N author non-byline.; Hodkinson T author non-byline.; Bamford R author non-byline.; Newman P author non-byline.; Cutting J author non-byline.; Barber Z author non-byline.; Grant C author non-byline.; Mason J author non-byline.; Bailey J author non-byline.;
• Is Part Of: BMJ open. Volume 6:Issue 9(2016)
• Publication Date: 2016-09-22
• Subjects: QUALITATIVE RESEARCH -- SURGERY -- Feasibility Studies -- WOUND MANAGEMENT; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2016-012635
• Languages: English
• ISSNs: 2044-6055

Abstract

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.