Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SU/2014/4748
Study information
Scientific title
The Bluebelle Study: a feasibility study of three wound dressing strategies in elective and unplanned surgery – Phase B
Acronym
Study hypothesis
This 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
NHS Health Research Authority - NRES Committee South West - Frenchay. 24/02/2015, ref: 15/SW/0008
Study design
Multi-centre pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgical site infections
Intervention
Participants, 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 type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
To 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 measures
1. 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 trial start date
01/11/2015
Overall trial end date
16/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients aged 16 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Total final enrolment
394
Participant exclusion criteria
1. 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
Recruitment start date
01/12/2015
Recruitment end date
31/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Royal Infirmary
University Hospitals Bristol NHS Foundation Trust
Queens Building
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom
Trial participating centre
Southmead Hospital Bristol
North Bristol NHS Trust
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Trial participating centre
Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust
Sponsor details
Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom
+44 117 3420233
research@UHBristol.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
A 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.
Intention to publish date
01/01/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2016 results of do dressings prevent infection of closed primary wounds after surgery?
In https://www.ncbi.nlm.nih.gov/pubmed/27220592 (added 25/01/2019)
2. 2016 results of feasibility work to inform the design of a randomized clinical trial of wound dressings in elective and unplanned abdominal surgery.
In https://www.ncbi.nlm.nih.gov/pubmed/27488730 (added 25/01/2019)
3. 2016 results of a mixed-methods feasibility study to inform a randomised controlled trial of surgical wound dressing strategies.
In https://www.ncbi.nlm.nih.gov/pubmed/27660321 (added 25/01/2019)
4. 2017 results of the development of a single, practical measure of surgical site infection for patient report or observer completion.
In https://www.ncbi.nlm.nih.gov/pubmed/28989524 (added 25/01/2019)
5. 2017 results of developing outcome measures to assess practical management of primary surgical wounds and patient experience.
In https://www.ncbi.nlm.nih.gov/pubmed/29180591
6. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30556594 (added 25/01/2019)
7. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31392958 (added 09/08/2019)