The Bluebelle study: a feasibility study of three wound dressing strategies in elective and unplanned surgery
Sponsor: University Hospitals Bristol
Wound infections occur commonly after surgery, leading to pain, discomfort and inconvenience for patients and increased healthcare costs for the NHS. There is controversy about the role of wound dressings in preventing infection. Although frequently used in adults after surgery, it is rare to apply dressings to wounds after surgery in children. A recent scientific review found no evidence to suggest that covering surgical wounds with dressings in adults and children reduces the risk of wound infection, or that any particular wound dressing is more effective than another. However, most of the studies identified for this review were small and had design faults. The studies also used different methods to define and measure wound infections.
Bluebelle is a feasibility study consisting of two phases. Phase A included interviews with health professionals and patients to explore views and acceptability about types of dressings and/or not using a dressing, with the aim to understand current practice in relation to dressings for particular procedures. We also wanted to develop a valid method for assessing wound infection, as the current methods vary and lack good agreement.
In phase B we conducted a pilot randomised controlled trial (RCT) to determine how easy it is to recruit participants into this type of study, whether expected recruitment rates can be met and whether the method for assessing wound infection developed in Phase A is valid. A total of 394 participants were randomised into the pilot RCT. The results of the study are currently being written up for publication, and information from the study will be used to decide if a large trial comparing wound dressings with no dressings is possible. The results will be published in 2019. If feasible the main trial is likely to include over 1,000 participants and will compare the effectiveness of different types of wound dressing in general and obstetric surgery.
Chief Investigator: Prof. Jane Blazeby