BLUEBELLE

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Introduction

Each year 4.5 million operations are performed in England and these are frequently complicated by wound infections. Whilst many wound infections resolve with simple treatment, the more serious ones cause pain, discomfort and may need prolonged hospital stays or further surgery. This has major costs for the health services. Every effort is therefore made to minimise risks of developing wound infections.

One area of controversy is the role of wound dressings. Wound dressings range from simple to complex with varying 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 surgical wounds in children. Evidence about the effects of wound dressings for the prevention of infection in surgical wounds, in adults and children, has been scientifically reviewed. This found no evidence to suggest that covering surgical wounds with dressings reduces the risk of wound infection, or that any particular wound dressing is more effective than another. The evidence, however, is poor, and most studies are small and had design faults. The review concluded that decisions on wound dressings should be based on dressing costs and acceptability issues, such as how dressings may influence management of tissue fluid leaking from the wound and it recommended more research. Another area of controversy is how wound infection should be defined and measured. Current definitions vary and there is a lack of consensus. Better ways of measuring wound infections are required that can be applied in everyday settings, and that includes issues of importance to patients and health services.

Aims

The overall aim of the Bluebelle feasibility study is to establish whether it is possible to carry out a randomised trial to compare the effectiveness and cost-effectiveness of complex, or simple, and/or no dressing to reduce wound infections following elective surgery and to develop a valid method for assessment of wound infections to be used in the main trial.

The study is divided into two main parts. The first part, Phase A, is currently underway and comprises a qualitative research project. This includes focused interviews undertaken with surgeons, nurses, midwives and patients in two surgical specialties (gastrointestinal and obstetrics). Interviews are being conducted in two types of hospital across two cities. This aims to investigate the current use of dressings and views about not using dressings and compare these findings with interviews carried out with staff (surgeons and nurses) in paediatric surgery (where dressings are not routinely used). Additional work to standardise clinical assessment of wound infections is also underway. This involves interviews with patients and staff to ask their views of the current questionnaires available to measure wound infections and also to ask them what additional issues the questionnaires should include.

The second part of Phase A includes a multicentre survey of current practice in peri-operative wound dressing use. This study aims to identify the types of dressing used to cover surgical wounds at the end of an operation and the factors which may influence this choice. Combined with the qualitative data outlined above, this information will be used to inform the planned interventional pilot study (Phase B).

The Bluebelle Study – Multicentre wound dressing survey

This study is ideally suited to the trainee research collaborative model, gathering detailed information at the point of care. This prospective study will collect data on the use of wound dressings in elective surgery. In the survey data will be collected over a 2 week period from 12/01/2015 until 25/01/2015.

Elective and emergency operations performed by both general surgeons (to include upper and lower gastrointestinal surgery) and obstetric surgeons at each centre will be eligible to be included in the study with permission of the named consultant. Vascular, breast and gynaecological procedures will be excluded.

Operations will be identified at each centre by the local investigating team in selected theatres. A minimum number of operations is required from each centre. For general surgery a minimum of 10 Emergency, 10 upper GI and 10 lower GI cases are required and for obstetrics a minimum of 10 elective and 10 emergency c-sections are required.

The objective of this study is to explore current practice in the use of peri-operative wound dressings and to understand local hospital policy for purchasing wound dressings. The primary objective of this study is to identify the type of dressings used to cover surgical wounds at the completion of elective operations. This includes the use of no dressing. Secondary objectives include data that may influence choice of wound dressings. In addition, a centre-specific questionnaire will address local policy in dressing use and procurement.

Resources

**Further details and full protocol to follow**

Wound dressing survey protocol 1.0

Bluebelle – Wound dressing surveys v1.0

**Please register your interest by e-mailing enquires@wmresearch.org.uk