A study looking at different dressings after surgery for soft tissue sarcoma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Other

This study is comparing 2 dressings to cover wounds after surgery. It is for people who are going to have surgery to remove soft tissue sarcoma at the Glasgow Royal Infirmary hospital.

More about this trial

Surgery is one of the main treatments for soft tissue sarcoma. Your surgeon removes as much of the cancer as possible. After removing the cancer, the surgeon closes the wound with stitches and covers it with a dressing.

Some surgeons use a waterproof absorbent dressing to cover the wound. Others, use a waterproof dressing attached to a vacuum pump. This is called a negative pressure dressing.

Doctors would like to know which type of dressing is better at preventing problems, such as infection. Everyone taking part in this study has their wound covered with either:

a waterproof absorbent dressing
a waterproof dressing attached to a vacuum pump

The main aim of this study is to find out which dressing is better at preventing complications (infection) after surgery.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this study if all of the following apply. You:

have soft tissue sarcoma
are going to have surgery to remove soft tissue sarcoma (wide local excision or planned marginal excision)
are aged between 16 and 85 years old

Who can’t take part
You cannot join this study if any of these apply.

you have had treatment, such as surgery or radiotherapy, on the same area where you are going to have the operation
your soft tissue sarcoma has spread to many places in your body and you can’t have surgery to remove it for any reason
you have had an operation to remove a part of the body such as an arm or leg (amputation)
you have an artificial device to replace a missing part of the body (endoprosthesis)
you are sensitive to dressings that stick to the skin (adhesive dressings)
you have any other medical condition or mental health problem that the trial team think may affect you taking part in this study

Trial design

Researchers need about 160 people who are going to have surgery for soft tissue sarcoma to take part. It is for people going to the Glasgow Royal Infirmary hospital for treatment.

You have surgery the same way as if you were not in this study. Your doctor will explain your treatment and what to expect.

At the end of your operation, the surgeon stitches the wound and covers it with 1 of the following:

a waterproof absorbent dressing
a waterproof dressing attached to a vacuum pump

The type of dressing you have is chosen at random by a computer. This is called a randomised trial. Neither you nor your doctor is able to decide which dressing you have.

Your doctor will tell you what to expect if you have the dressing attached to a vacuum pump. The pump is called Activac and it helps to drain fluid from the wound.

The Activac pump is small and comes with a carry case. So, you can walk around as normal.

After the operation, you go back to the ward or the high dependency unit. Your nurse will look after you until you recover. You have painkillers if you need it. They also monitor the wound. This is the same for both groups.

Your surgeon or research nurse will tell you for how long you need to keep the dressing and vacuum pump. This is usually about 6 days. During this time, your nurse will empty the pump if needed.

Hospital visits

There are no extra hospital visits as part of this study. After the operation, your doctor will see you regularly to check how you are. They also check how the wound is healing. This is the same as the standard treatment.