Condition category
Surgery
Date applied
18/03/2014
Date assigned
20/03/2014
Last edited
01/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 will involve interviews of 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 will also be 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 will be 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) will be carried out to explore if there were any surgical site infections, the main problems encountered and the signs and symptoms relevant to them. Participants will be asked to comment on a questionnaire developed by the research team. The study team will discuss the findings to inform the creation of two new measures (one for staff to complete and one patient-reported measure).
3. The new questionnaires will be pre-tested (patients and staff). They will be asked to complete the measure developed and comment on their understanding of each item. The wording, format and rating for possible items will then be discussed by the research team and suggested improvements or alternatives to those used in existing measures will be 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 we will get 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. We do not expect any risks to participants taking part in this interview study. 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 will be contacted. Participants will be reminded that they can end the interview and/or withdraw from the study at any time.

Where is the study run from?
The study will be run from the following hospitals in the UK:
1. University Hospitals Bristol NHS Foundation Trust
2. North Bristol NHS Trust
3. University Hospitals Birmingham NHS Foundation Trust
4. Birmingham Children's Hospital NHS Foundation Trust
5. Sandwell and West Birmingham Hospitals NHS Trust
6. Birmingham Women's NHS Foundation Trust

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

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

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jane Blazeby

ORCID ID

Contact details

University of Bristol
School of Social & Community Medicine Canyage Hall
39 Whatley Road
Clifton
Bristol
BS8 2PS
United Kingdom
+44 (0)117 928 7332
j.m.blazeby@bristol.ac.uk

Type

Scientific

Additional contact

Mrs Jenny Lamb

ORCID ID

Contact details

University of Bristol
School of Social & Community Medicine Canyage Hall
39 Whatley Road
Clifton
Bristol
BS8 2PS
United Kingdom
-
jenny.lamb@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/200/04

Study information

Scientific title

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

Acronym

Study hypothesis

There are no specific hypotheses for this qualitative study. Instead, the study aims to explore the views of healthcare professionals and patients about the use of surgical wound dressings (complex, simple or no dressing) after common operations. We will also be investigating ways to improve the monitoring of wound sites and the diagnosis of wound infections.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1220004
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/123356/PRO-12-200-04.pdf

Ethics approval

London - Camden & Islington ethics committee, 10/04/2014, REC No: 14/LO/0640

Study design

Qualitative design including interviews and questionnaires

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Wound Infection

Intervention

This is non-interventional study. All interviews will take between 30-45 minutes and there is no planned follow up. Interviews to explore participant perspectives on wound dressing will include questions focusing on participant background details, experiences of wound care (patients)/dressing usage (healthcare professionals), views about the use of 'no dressings' and perspectives on a study of dressing type. Participants who are interviewed to explore experiences of surgical site infection will be asked to complete and comment on modified versions of the surgical wound healing and ASEPSIS post-discharge questionnaires. Participants taking part in the cognitive interviews will be asked to complete a new measure of surgical site infection which will be developed based on the two questionnaires and participant feedback.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

To establish patient and staff views about wound dressings

Secondary outcome measures

To develop two comprehensive measures of Surgical Site Infection (one for observer completion and the second for patient-reported outcomes) that will be validated in a future pilot randomised controlled trial

Overall trial start date

01/06/2014

Overall trial end date

31/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged 18 or over undergoing elective abdominal surgery, including, but not limited to, gastrectomy for benign and malignant disease, cholecystectomy, small or large bowel resection for benign or malignant conditions, abdominal wall hernia surgery (inguinal, femoral, incisional, epigastric and paraumbilical) or elective obstetric surgery (caesarean section)
2. Consultant surgeons, senior trainees, qualified nurses and midwives involved in the care and management of patients undergoing elective abdominal, obstetric or paediatric surgery

Added 24/11/2014:
An amendment has been approved (18/11/2014) to allow the inclusion of emergency abdominal surgery and emergency caesarean patients who have had an infection.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

We expect to carry out a total of 170 interviews

Participant exclusion criteria

1. Paediatric patients
2. Patients unable to give written consent
3. Patients undergoing types of surgery other than abdominal and obstetric surgery
4. Patients having emergency surgery
5. Staff who do not work in field of abdominal, paediatric or obstetric surgery

Recruitment start date

26/06/2014

Recruitment end date

31/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Bristol
BS1 3NU
United Kingdom

Trial participating centre

Birmingham Women's NHS Foundation Trust
Birmingham
B15 2TG
United Kingdom

Trial participating centre

North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Birmingham Children's Hospital NHS Foundation Trust
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Sandwell and West Birmingham Hospitals NHS Trust
Birmingham
B71 4HJ
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

R&D Office
Level 3
Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
+44 (0)117 342 0233
research@uhbristol.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Health Technology Assessment (HTA), Ref: 12/200/04

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We have plans to submit a number of papers for publication in the early part of 2015. These include results from the case studies performed in Phase A and a conceptual and literature work performed about the definitions of dressings and ‘no dressings’. We will also submit a protocol paper for the next phase of the study (Phase B) which will be a pilot randomised trial.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes