The Bluebelle Study: Phase A
Research type
Research Study
Full title
The Bluebelle Study: a feasibility study of complex, simple and absent wound dressings in elective surgery (Phase A)
IRAS ID
145524
Contact name
Jane M Blazeby
Contact email
Sponsor organisation
UH Bristol NHS Foundation Trust
Research summary
Each year 4.5 million operations are performed in England and surgical site infections (SSIs) complicate up to 25% of procedures. Whilst many SSIs may resolve with simple antibiotic treatment, the more serious ones cause morbidity and major costs for the NHS and pain, discomfort and inconvenience for patients (and, after some operations, threaten the principal outcome of the operation, the future health of the patient and may even be life threatening). Every effort, therefore, is made before, during and after surgery to minimise risks of developing SSI. One area of controversy is the role of wound dressings. Wound dressings range from simple (basic) to complex (advanced) dressings with absorbent or low adherence properties and some complex dressings may interact with the wound to improve healing and potentially reduce SSI. Evidence about the effects of wound dressings for prevention of SSI in surgical wound healing has been systematically reviewed. The review found no evidence to suggest that covering surgical wounds with dressings reduces the risk of SSI, or that any particular wound dressing is more effective than another in reducing scarring, controlling pain, promoting patient acceptability or ease of dressing removal. The evidence, however, is poor, and most studies are small and at high risk of bias. The overall aim of the Bluebelle feasibility study is to establish whether it is possible to carry out a major randomised trial to compare the effectiveness and cost-effectiveness of complex, or simple, and/or no dressing to reduce SSI following elective surgery. The Bluebelle study is in two parts, the preliminary work (Phase A), is a necessary precursor for the second part (Phase B) which is a pilot RCT. This is an ethical submission for Phase A which aims to assess the scope for comparisons of simple, complex and/or no dressings in a pilot trial and to develop and pre-test a comprehensive patient centred measure to assess SSI. Phase A will also undertake work with professional groups and the literature to define and categorise dressing into three groups (complex, simple and ’no dressing’).
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
14/LO/0640
Date of REC Opinion
10 Apr 2014
REC opinion
Further Information Favourable Opinion