The Bluebelle pilot trial: Is it possible to recruit participants to a trial of different methods of dressing surgical wounds, one of which is to use no dressing?

ISRCTN ISRCTN49328913
DOI https://doi.org/10.1186/ISRCTN49328913
Secondary identifying numbers SU/2014/4748
Submission date
18/09/2015
Registration date
20/10/2015
Last edited
07/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Wound infections are a common complication after surgery, which are a major cost for the NHS. The skin usually acts as a barrier against infection, protecting the blood and internal organs. When a cut is made during an operation to allow the surgery to be performed (surgical site), bacteria can potentially enter the body causing an infection. Wound dressings are commonly used to prevent infections of surgical sites in adults, however this practice is controversial. There is not enough evidence to say that wound dressings can help prevent surgical site infections (SSI). For example, in children it is rare to use wound dressings after surgery and the rate of SSI’s does not seem to have been affected by this. Previously, healthcare professionals and patients were interviewed, in order to find out their opinions about different types of dressings. The aim of this initial study is to look at the use of different would dressings in order to reduce the amount of SSI’s. This study will also show whether it would be feasible to carry out a larger study looking at the use of different dressings on surgical wounds.

Who can participate?
Adult surgery patients who be having subcuticular sutures for wound closure.

What does the study involve?
Participants are randomly allocated into one of three groups. After undergoing their scheduled surgical procedure, the surgical site is sewn up with stiches (sutured) and then treated in different ways. For those in the first group receive a “simple dressing”. This involves a covering that it directly placed over the whole of a closed-up wound. Those in the second group receive a “tissue adhesive-as-a-dressing”. This is “glue” that is applied directly to the skin to “seal” the wound edges together. Those in the third group do not receive any covering of their wound after their operation. Thirty days later, all participants visit the clinic for a follow up examination of their wound.

What are the possible benefits and risks of participating?
This study does not have any specific benefits for participants, however it will help increase knowledge which could help future patients. There are no risks of participating in this study, as all three techniques are currently used by surgeons. If a wound problem occurs (e.g. infection or leakage) it will be treated in the normal way.

Where is the study run from?
1. Bristol Royal Infirmary (UK)
2. Southmead Hospital Bristol (UK)
3. Queen Elizabeth Hospital Birmingham (UK)

When is the study starting and how long is it expected to run for?
November 2015 to August 2016

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

Who is the main contact?
Ms Helen Talbot

Contact information

Prof Jane Blazeby
Public

University of Bristol
School of Social & Community Medicine
Canynge Hall
39 Whatley Road
Clifton
Bristol
BS8 2PS
United Kingdom

Study information

Study designMulti-centre pilot randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe Bluebelle Study: a feasibility study of three wound dressing strategies in elective and unplanned surgery – Phase B
Study objectivesThis pilot randomised controlled study is to establish whether it is possible to carry out a major randomised study to compare the effectiveness and cost-effectiveness of simple dressing, tissue adhesive-as-a-dressing and no dressing to: reduce surgical site infection (SSI) and improve aspects of wound management and patients’ experience of the care of their surgical wounds following elective and unplanned abdominal and obstetric (caesarean section) surgery.
Ethics approval(s)NHS Health Research Authority - NRES Committee South West - Frenchay. 24/02/2015, ref: 15/SW/0008
Health condition(s) or problem(s) studiedSurgical site infections
InterventionParticipants, confirmed as having provided consent and as eligible for the study, will be randomised via a secure web-based database. Participants will be randomised to one of six groups, comprising all permutations of three wound dressing strategies (see below) and two times of disclosure of allocation to a dressing strategy (before or after wound closure).

1. Simple Dressing: A covering (opaque or transparent) that is directly applied to an already closed wound, over the entirety of the wound. It has adherent properties around its perimeter, or, its entire surface which is in contact with the skin. It may or may not have absorbent properties.

2. Tissue adhesive-as-a-dressing: Tissue adhesives are topical skin adhesives and in this study they will be applied to the surface of an already closed primary wound, acting as a dressing. They will not be applied with the intention to close the wound (i.e. below skin level), and will be applied according to the manufacturers’ instructions for use after wound closure.

3. ‘No’ dressing: For those allocated to no dressing, at the end of the operation when the skin has been closed, no dressing at all or tissue adhesive is applied to the wound. The wound is therefore left exposed without a covering as is the standard approach for many types of surgery.

For all of the interventions, a simple gauze swab can be applied to an area that is, for example, oozing. This may be taped in place temporarily (but not around its entire perimeter) and will not have therapeutic properties. If the oozing continues the clinical team may apply any dressing of choice to the wound(s) (or re-suture it if necessary). This will be documented in the CRFs. Wounds will be treated pragmatically and dressings left on as per normal practice.
The follow-up duration is 4-8 weeks from wound closure, (the same for the 3 arms) and includes:
Completion of: a questionnaire measure relating to the participant's management of the wound by a health care professional within 24 hours prior to discharge) and a questionnaire relating to the experience of the wound(s) by the participant within 48 hours of discharge. (Day Cases: Completion of Wound Experience and Practical Wound Management questionnaires within 48 hours of discharge).
On about day 15 and, where possible, at any time the participant considers there is a problem with their wound: Completion of an EQ-5D-5L (electronically or paper version if no access to electronic version).
For the 4-8 week follow-up assessment (which can be by phone or at clinic visit/home visit for women who have had a C-section):
Completion of a participant reported measure of SSI prior to a clinician assessment and a health status questionnaire (EQ-5D 5L) and provide information on any adverse events and use of health services since discharge from hospital. The clinician will complete a standard reference assessment and then the SSI measure.
Wound photos may be taken, with appropriate consent and in adherence to local policy, by clinicians (in theatres and/or at 30 day follow-up) and/or participants (for 30 day assessment and at any time they consider there to be a problem with their wound(s). Photos will be submitted to a secure database and will facilitate the exploration of a method for remote and blinded assessment of wounds using digital photography.
Intervention typeProcedure/Surgery
Primary outcome measureTo establish whether recruitment into the main trial is possible, by recording the number of patients screened, eligible and randomised into the pilot trial.
Secondary outcome measures1. Health status is measured using the EQ-5D-5L will be collected at baseline, day 15, 4-8 weeks and between these time points if a participant considers that there is a problem with the wound(s)
2. Participant symptom experience is measured using the Wound Experience Questionnaire will be completed within 48 hours of discharge
3. Practical wound management is measured using the Wound Management Questionnaire will be completed by a nurse up to 24 hours before discharge if the participant is an inpatient or up to 48 hours after discharge if the participant is a day case
4. Surgical site infection post discharge is measured using the Wound Healing (SSI) questionnaire will be completed by the participant and a member of the research team at the 4-8 week assessment. A member of the research team will also complete a reference SSI assessment at the 4-8 week assessment.
5. Qualitative research will be carried out alongside the trial to investigate facilitators and barriers to recruitment and possible reasons for non-adherence
Overall study start date01/11/2015
Completion date16/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants330
Total final enrolment394
Key inclusion criteria1. Adult patients aged 16 years or over
2. Patients undergoing primary elective or unplanned abdominal general surgery (including, but not limited to gastrectomy for benign or malignant disease, cholecystectomy, anti-reflux procedures, hepatic resection, small or large bowel resection for benign or malignant conditions, abdominal wall hernia surgery (inguinal, femoral, incisional, epigastric and paraumbilical)) or elective or unplanned obstetric surgery (caesarean section). (NB Potential participants undergoing simultaneous abdominal and chest surgery are eligible but only the abdominal wounds will be included in the study interventions)
3. The wound is intended to be closed at the end of the procedure with sutures or clips
4. The potential participant is willing to attend follow-up for 4-8 weeks
Key exclusion criteria1. Patients who have undergone abdominal or other major surgery less than three months before the index operation
2. Patients who have allergies to dressings or other contraindication to dressings
3. Patients undergoing groin surgery
4. Patients undergoing surgery which result in only internal wounds (e.g. intra vaginal surgery)
5. Prisoners and adults lacking capacity to consent
6. Ability to read/understand English
Date of first enrolment01/12/2015
Date of final enrolment31/08/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Bristol Royal Infirmary
University Hospitals Bristol NHS Foundation Trust
Queens Building
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom
Southmead Hospital Bristol
North Bristol NHS Trust
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom

Sponsor information

University Hospitals Bristol NHS Foundation Trust
Hospital/treatment centre

Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
England
United Kingdom

Phone +44 117 3420233
Email research@UHBristol.nhs.uk
ROR logo "ROR" https://ror.org/04nm1cv11

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/01/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planA final report will be submitted for publication in the NIHR Journals Library in 2017, as required by the contract for funding for the trial. We also intend to publish aspects of the study, primarily relating to its feasibility, in peer reviewed journals.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications 26/11/2017 Yes No
Other publications 24/05/2016 25/01/2019 Yes No
Other publications 01/11/2016 25/01/2019 Yes No
Other publications 01/07/2017 25/01/2019 Yes No
Other publications 22/09/2016 25/01/2019 Yes No
Results article results 01/02/2019 25/01/2019 Yes No
Results article results 01/08/2019 09/08/2019 Yes No
HRA research summary 28/06/2023 No No
Protocol article 29/08/2017 07/11/2023 Yes No

Editorial Notes

07/11/2023: Publication reference added
09/08/2019: Publication reference and total final enrolment number added.
25/01/2019: Publication references added