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Prof Jane Blazeby


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Be Part of Research - Trial Details - 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?
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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?

Not Recruiting

Open to: All Genders

Age: Adult

Bristol Bristol Birmingham

Medical Conditions

Surgical site infections

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Dec 2015 31 Aug 2016

Publications

2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/291805912016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27220592 (added 25/01/2019)2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27488730 (added 25/01/2019)2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28989524 (added 25/01/2019)2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27660321 (added 25/01/2019)2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30556594 results (added 25/01/2019)2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31392958 results (added 09/08/2019)2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28851399/ (added 07/11/2023)

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.


Adult surgery patients who be having subcuticular sutures for wound closure.

You can take part if:



You may not be able to take part if:


1. Patients who have undergone abdominal or other major surgery less than three months before the index operation2. Patients who have allergies to dressings or other contraindication to dressings3. Patients undergoing groin surgery4. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

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

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.

Prof Jane Blazeby



The study is sponsored by University Hospitals Bristol NHS Foundation Trust and funded by National Institute for Health Research.



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Read full details for Trial ID: ISRCTN49328913
Last updated 07 November 2023

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