Title: The Bluebelle study: FeasiBiLity stUdy of complEx simple and aBsEnt wound dressings in eLective surgery
Funder: Department of Health (England)

Abstract: Each year 4.5 million operations are performed in England and surgical site infections (SSIs) complicate between up to 25% of procedures. Whilst many SSIs resolve with simple treatment the more serious ones cause morbidity and major costs for the NHS. Every effort therefore is made to minimise risks of developing SSI. One area of controversy is the role of wound dressings. Wound dressings range from simple to complex with absorbent or low adherence properties and some (complex) dressings may interact with the wound to improve healing. Application of wound dressings is standard practice following surgery in adults but it is rare to apply dressings to wounds in paediatric surgery. Evidence about the effects of wound dressings for prevention of SSI in surgical wound healing in both adult and paediatric practice 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. The evidence however is poor and most studies are small and at high risk of bias. The review concluded that decisions on wound dressings should be based on dressing costs and acceptability issues such as how dressings may influence exudate management and recommended more research. Another area of controversy is the definition of SSI which has been summarized in another review recently. It concluded that SSI definitions varied between surveillance programmes and hospitals and lacked good agreement. It recommended research to focus on development of an SSI definition with satisfactory psychometric properties that can be applied in everyday settings that includes post discharge surveillance and which is formulated with the objective of detecting SSIs that are important to patients and health services. This review recommended that initial work develop a gold standard reference system to serve as a comparison to alternatives such as patient self diagnosis. The overall aim of the Bluebelle feasibility study therefore 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 and to develop a valid method for assessment of SSI to be used in the main trial.The study will have two parts the first being a necessary precursor to the second. Initially focused interviews will be undertaken with surgeons nurses/midwives and patients in two adult surgical specialities (in two types of hospital in two cities) to investigate the current use of dressings and views about not using dressings so that we can compare these findings with interviews carried out with surgeons and nurses in paediatric surgery (where dressings are not routinely used). The aim of this qualitative research is to understand current practice in relation to dressings for particular procedures and to explore views and acceptability about types of dressings and/or not using a dressing. Interviews will be focused on perspectives of wounds and dressings and sufficient will be undertaken until new data do not add to the understandings gained about views from each group. In this phase we will identify types of dressings in use their costs and contextual information and the research team will categorise them into pragmatic groups with defined boundaries (i) complex and (ii) simple. A definition of no dressing will be agreed and assessments of the costs of dressings made. We will undertake methodological work to standardise a clinical reference assessment of SSI and to modify questionnaires to assess SSI post discharge (CDC and ASEPSIS). The qualitative data the information about the dressings and the work on SSI assessment will be considered within team meetings which will establish whether a two or three arm pilot RCT can be performed. The second phase the pilot RCT will be in two areas of elective adult surgery (general and obstetric surgery) and be in hospitals in two cities (Bristol and Birmingham). It will investigate recruitment and adherence issues. The issue of recruitment will be addressed by establishing the numbers of eligible and randomised patients in each centre ascertaining recruitment pathways and identifying and tackling emerging barriers to recruitment. Recruitment will be performed by surgical trainees who are part of the West Midlands Research Collaborative (WMRC http://www.wmresearch.org.uk/) and the Severn and Peninsula Audit and Research Collaborative for Surgeons (SPARCS http://www.sparcs.org.uk/). The collaboratives have an unprecedented record in recruiting patients into RCTs in surgery. In obstetrics work will be undertaken by research midwives. The pilot trial will investigate levels of adherence with the allocated dressing type and the follow up protocol (including collection of key outcome data) through detailed reports and non-participant observation. It will undertake a validation study of the methods for SSI assessment developed in the first phase explore methods for blinding of outcome assessors and identify the main cost drivers for the dressing types. The pilot RCT will be open for nine months. During this time it is expected that over 1000 patients will be screened for trial eligibility. At the end of phase B meetings between the research team will establish the definitive design for the main trial using learning from the pilot RCT (whether randomisation to no dressings is feasible and acceptable in particular types of surgery) and the required sample size based upon the hypotheses to be tested. The main trial may investigate if (i) no dressings are non-inferior to simple dressings and/or whether (ii) complex dressings are superior to simple dressings. It will address cost-effectiveness of alternative approaches to inform health policy. The feasibility study will be led by an experienced team and trials unit and it will include an academic lead of patient involvement. It will be a collaboration between two Royal College of Surgeons of England Surgical Trials Centres and the MRC ConDuCT-II Hub. No ethical issues are anticipated in this study which will yield a detailed understanding of the use and acceptability of dressings as well as a feasible and efficient main RCT design.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.3 MEDICAL DEVICES
Health categories: INFECTION