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The Bluebelle study: Feasibility study of complex, simple and absent wound dressings in elective surgery

Funding body/stream

NIHR - Health Technology Assessment

Chief investigator

Professor Jane Blazeby

Institution

University Hospitals Bristol NHS Foundation Trust

Start dateand duration

1st June 2014 for 2 years

Amount

£391,253

Summary

Each year 4.5 million operations are performed in England and these may be complicated by wound infections (surgical site infections, SSIs) in up to 25% of procedures. Whilst many wound infections resolve with simple treatment, the more serious ones cause complications and major costs for the health services. Every effort, therefore, is 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 wounds in surgery in children. Evidence about the effects of wound dressings for prevention of infection in surgical wounds in practice 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 the definition of wound infection.

Current definitions vary and there is a lack of good agreement. Better ways of measuring wound infections are required that can be applied in everyday settings, and that are important to patients and health services. 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 wound infections following elective surgery and to develop a valid method for assessment of wound infections to be used in the main trial.

Impact(why is research important? /Expected Output of Research)

Expected Output of Research/Impact

The main output of this research is to inform the design of the main trial and to decide whether this is going to include three arms (with a 'no dressing arm'). The study will also produce a valid and reliable method for assessment of SSI after hospital discharge combining the two most commonly used systems. This will be of benefit to the Health Protection Agency and other studies and hospital audits.

Several papers relating to an in-depth understanding about dressings and current use will be published and suggestions for further research if a trial is not feasible.

Patient and public involvement

This study was developed and refined on the basis of patients and clinicians' experiences of wound dressings after surgery, including the views of nurses and surgeons who do not routinely use dressings with paediatric patients. Patients and clinicians provided their views about not using dressings with adult and paediatric patients, and considered the study as important work with the potential to impact on patient wellbeing and the NHS. There was particular concern about risks of deep infection in cardiac and orthopaedic surgery and therefore this application has been refined not to include these surgical specialities.

The academic lead for the PPI work (Gooberman-Hill) runs the Patient Experience Partnership in Research (PEP-R) group, a patient forum recently featured in INVOLVE's newsletter and training case studies for training. Since 2010, PEP-R has been facilitating partnership between patients and researchers to identify research priorities and to design musculoskeletal research. Experience from the success of PEP-R will inform the design and implementation of PPI in this study, including the support that patient representatives will receive.

Patient involvement will take place throughout the study with a dedicated group ('forum') of people with experience (as patients or carers) of each type of surgery. Forum members will be invited through clinicians at participating NHS Trusts and will be identified with diversity in mind. In facilitated forum meetings planned for months 10,16 and 22, inclusive strategies will achieve the following:

• Design and refinement of recruitment materials

• Advise on interventions (acceptability of no dressings) and design of phase B and main trial

• Specification of dissemination strategies and developing material

Forum members will receive tailored support from the qualitative researcher based in Bristol with guidance from the PPI lead. They will also have access to learning and development events provided by 'People and Research West of England', of which the host organisations are stakeholder members. As the patient forum will comprise members from diverse patient groups, we will also conduct an evaluation. In keeping with INVOLVE's guidance, forum members will be paid for their time and expenses.

Links to further information

http://www.nets.nihr.ac.uk/projects/hta/1220004

http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=16668