ArticleBMJ open2016
Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies.
Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic review of the use of cyanoacrylate glue in addition to standard wound closure in the prevention of surgical site infection.International wound journal · 2019Pooled it
- Adaptation of the Wound Healing Questionnaire universal-reporter outcome measure for use in global surgery trials (TALON-1 study): mixed-methods study and Rasch analysis.The British journal of surgery · 2023Trial
- Clinicians' Views of Patient-initiated Follow-up in Head and Neck Cancer: a Qualitative Study to Inform the PETNECK2 Trial.Clinical oncology (Royal College of Radiologists (Great Britain)) · 2022Trial
- Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT.Health technology assessment (Winchester, England) · 2021Trial
- Trial
- Trial
- Exploring the views of patients' and their family about patient-initiated follow-up in head and neck cancer: A mixed methods study.European journal of cancer care · 2022Article
- Article
- Article
- Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal.International wound journal · 2019Article
- Validation of the Bluebelle Wound Healing Questionnaire for assessment of surgical-site infection in closed primary wounds after hospital discharge.The British journal of surgery · 2019Article
- Developing outcome measures assessing wound management and patient experience: a mixed methods study.BMJ open · 2017Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
Abstract
objectivesDressing 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.
designMixed methods, including semi-structured interviews and document analysis.
setting6 UK hospitals.
participants51 patients and 92 clinical professionals from abdominal surgical specialities.
resultsProfessionals 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.
conclusionsPre-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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.