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Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection: A randomised external pilot trial

DEFeND

Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection: A randomised external pilot trial
Funding Dept. Health (NIHR)
Portfolio Cancer
Interventions Surgery
Randomised Yes
Status In Follow-up
Start Date 01-Nov-2018

Plain English Summary
Background and study aims
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 can be 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 treatment has shown that avoiding complications is very important. Giving patients a substance that copies the blood clotting process, called Fibrin Sealant, 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, reducing the space for blood to collect in. Fibrin Sealants are natural products derived from the same human blood that is used for blood transfusions and are sprayed directly into the wound. Unfortunately, there is no high quality research that has been able to answer whether Fibrin Sealants can prevent complications after neck dissection. Therefore a clinical trial has been designed to help answer this important question. However, before this can be started a miniature version of the trial (pilot study) needs to be conducted to make sure it has been designed in the best possible way and improve the design of the future trial, which will find out whether or not Fibrin Sealants can really help avoid complications.

Who can participate?
Patients over 18 years old who are due to have a neck dissection

What does the study involve?
Participants are randomly allocated to either receive Fibrin Sealant during their Surgery or have their Surgery as normal without it. They are followed up for 6 weeks after the date of their Surgery. This includes their hospital in-patient stay and two scheduled outpatient clinic appointments. Any unscheduled hospital visits within the 6 week period are also included.

What are the possible benefits and risks of participating?
Taking part in this study does not have an effect on the participants’ cancer treatment. They will not be restricted in taking any drugs they may need or in having any further treatment. There are no specific benefits to taking part other than the opportunity to take part in surgical research. The study has been designed to minimise extra tests and hospital visits so that participation is as easy as possible. Surgeons up and down the country are already using Fibrin Sealants but this is not based on high quality evidence. Participants will be helping to design a ‘full’ trial that is as effective and efficient as possible. It is hoped that the ‘full’ trial will answer whether or not Fibrin Sealants are beneficial to patients undergoing neck dissection Surgery. Fibrin Sealants are considered to be very safe products and serious risks are very rare. The manufacturer reports the following potential risks:
1. Itchiness of the skin of the neck (between 1 – 10 patients out of a hundred). The doctor may treat this with antihistamines (allergy medicines) depending on how problematic this is.
2. Fluid collection under skin (less than 1 patient out of a hundred). Most fluid collections do not require treatment as the body will eventually absorb the fluid. If the fluid collection is large or problematic, the doctor may drain the fluid. This may be done by either drawing the fluid out using a syringe or formally opening the wound and letting the fluid out.
3. Severe allergic reaction (less than 1 patient out of a hundred). If participants develop a severe allergic reaction it will normally develop during or immediately after the Surgery. If signs and symptoms of allergy are noted they will receive treatment as a matter of urgency.
4. If the surgeon holds the spray too close to the blood vessels in the neck, air may enter the blood vessel causing a serious complication known as an “air embolism”. Patients who get “air embolisms” are at increased risk of heart attacks, strokes and breathing problems. Fortunately this is very rare as there have only ever been 6 reported cases of life threatening “air embolism” out of many thousands of patients who have already been given Fibrin Sealants over the years. There have been no reported cases of “air embolism” from the type of Fibrin Sealant used (ARTISS, Baxter Healthcare Ltd). Every surgeon who uses the fibrin sealant in this study will be trained on how to avoid this complication.
5. Because the Fibrin Sealant is taken from human blood that is used in blood transfusions, there is a theoretical risk of catching a blood-borne virus (e.g. hepatitis or HIV). People who donate their blood are always carefully selected to minimise the risk of transmitting viruses. Also the Fibrin Sealant has been carefully checked and treated to prevent contamination with viruses. Despite these efforts, it cannot be guaranteed that the Fibrin Sealant is free of viruses. There have been no reported cases of patients catching viruses from Fibrin Sealants. In the very unlikely event that participants do catch a virus, they will be referred to a specialist for treatment.

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