The Bluebelle Study: complex, simple and absent wound dressings in elective surgery: Phase A

Plain English Summary

Background and study aims
Wound infections are a common complication of surgical procedures, and are a major cost for the NHS as well as a cause of pain, discomfort and inconvenience for patients. Although every effort is made to reduce the risk of wound infection, controversy remains around the role of wound dressings in preventing infection. A wide variety of wound dressings are available ranging from simple to complex and some (complex) dressings may interact with the wound to improve healing. However, whilst application of wound dressings is standard practice following surgery in adults, it is rare to apply dressings to wounds in surgery in children. There is 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 faults. Improvements in the way that wound infection is defined and measured are also required, as the current methods vary and lack good agreement. This study involves interviews with health professionals and patients, with the aim 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. Patients and health professionals are also asked their views on the questionnaires currently available to measure wound infections and what additional issues the questionnaires should include.

Who can participate?
Surgeons, nurses, midwives and patients can take part if they are involved in the care and management of patients undergoing non-emergency abdominal, obstetric or paediatric surgery. Patients are eligible if they are aged 18 or over and are undergoing non-emergency abdominal surgery or non-emergency obstetric surgery (caesarean section).

What does the study involve?
Participants may be asked to be involved in one or more of the following interviews:
1. One-to-one research interviews are undertaken with participants (staff and patients) to understand current idea on dressing use in surgery and to explore attitudes towards a study of dressing type.
2. Semi-structured interviews (staff and patients) are carried out to explore if there were any surgical site infections, the main problems encountered and the signs and symptoms relevant to them. Participants are asked to comment on a questionnaire developed by the research team. The study team discusses the findings to inform the creation of two new measures (one for staff to complete and one patient-reported measure).
3. The new questionnaires are pre-tested (patients and staff). They are asked to complete the measure developed and comment on their understanding of each item. The wording, format and rating for possible items are then discussed by the research team and suggested improvements or alternatives to those used in existing measures are sought.

What are the possible benefits and risks of participating?
Some people find that taking part in interviews helps them talk through their views and experiences, and that this can be helpful for them. The information from the study will be very helpful to the NHS and to future patients needing operations that carry a risk of wound infection that might be influenced by the use of wound dressings. No risks are expected for participants. However, it is possible that patients may be upset by being asked to talk about their experiences of surgical site infections and wound dressings. If this occurs the clinical team are contacted. Participants are reminded that they can end the interview and/or withdraw from the study at any time.

Where is the study run from?
1. University Hospitals Bristol NHS Foundation Trust (UK)
2. North Bristol NHS Trust (UK)
3. University Hospitals Birmingham NHS Foundation Trust (UK)
4. Birmingham Children's Hospital NHS Foundation Trust (UK)
5. Sandwell and West Birmingham Hospitals NHS Trust (UK)
6. Birmingham Women's NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run?
June 2014 to May 2015

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Miss Lucy Ellis
pslae@bristol.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre

R&D Office
Level 3, Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom

Phone	+44 (0)117 342 0233
Email	research@uhbristol.nhs.uk
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

09/08/2019: Publication reference and total final enrolment number added.
11/08/2017: Publication reference added.