DEFeND
Research type
Research Study
Full title
DEFeND: Determining the effectiveness of Fibrin Sealants in reducing complications in patients undergoing lateral neck dissection: a randomised external pilot trial
IRAS ID
234851
Contact name
Andrew Schache
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN99181100
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
A neck dissection is an operation to remove the glands in the neck either because they have cancer in them or they are at risk of cancer spreading to them. Complications after neck dissection are a significant problem for patients and may affect their quality of life. Research on understanding the feelings of patients who have had head and neck cancer, has shown that avoiding complications is very important to them.
We have found evidence that by giving patients a substance that copies the blood clotting process called Fibrin Sealant, we may be able to protect them from complications. This is because this substance can seal areas of bleeding and stick the raw surfaces of the wound together. Unfortunately, there is no high quality research that has been able to answer whether Fibrin Sealants can prevent complications after neck dissection. Therefore we have designed a clinical trial to help us answer this important question. However, before this can be started we need to conduct a miniature version of the trial to make sure it has been designed in the best possible way.
Patients who are due to have a neck dissection, are over 18 years old and have capacity to consent will be included in the study. We will exclude patients who may be pregnant or may have an allergy to Fibrin Sealant.
This study will be conducted in Aintree University Hospital and Queen Victoria Hospital and will last for 12 months. Participants will be randomised to either receive Fibrin Sealant during their surgery or have their surgery as normal without it. The main questions we aim to answer are:
1. Can we recruit patients?
2. Do all aspects of the study design work well together?
3. How many patients do we need in the 'full' trial?REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0209
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion