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Enrolling by invitationNAINTERVENTIONAL

Monitoring Free Tissue Transfer Hemodynamics Using NIRS

This study is looking at a new, gentle way to monitor transplanted skin after head and neck cancer surgery. When surgeons move skin from one part of the body to another (called free tissue transfer) to repair a wound, there's a small risk the new tissue won't get enough blood. If this happens, the tissue could die. Currently, doctors check by looking at the tissue, but this new device uses light to continuously monitor blood supply. The aim is to find any problems with blood flow very early so doctors can act quickly, potentially saving the transplanted tissue and avoiding further surgery. It hopes to make monitoring easier for patients and medical staff.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
University of British Columbia
Enrolment target
60
Start
20 Apr 2025
Estimated completion
01 Sep 2027

What is this study about?

When doctors remove cancer, especially from the head and neck, they often need to repair the area using skin, muscle, or bone from another part of your body. This procedure is called 'free tissue transfer'. It's a clever way to help you heal and recover your appearance and function. However, a small but important challenge is making sure the new, transplanted tissue receives enough blood. Surgeons carefully connect tiny blood vessels, but sometimes these connections can have problems, leading to poor blood flow.

If the transplanted tissue doesn't get enough blood, it can be seriously damaged or even die. Currently, doctors regularly check the transplanted area by looking at it for signs of trouble. This usually requires experienced staff and can't be done constantly. If a problem is found quickly, doctors can take you back to surgery to try and fix the blood supply, which can save the tissue and prevent more serious complications.

This study is testing a new, gentle device that sticks to your skin and uses a special light to continuously check the blood flow in the transplanted tissue. The idea is that this device could spot problems with blood supply much earlier and more reliably than current methods. If successful, this new monitoring system could help doctors intervene sooner, improve the success rate of these surgeries, and potentially reduce the need for more complex treatments or longer hospital stays for patients undergoing head and neck cancer reconstruction.

Key takeaways

  • The study tests a new device for monitoring blood flow after head and neck cancer surgery.
  • It aims to detect problems with transplanted tissue's blood supply earlier.
  • The device is gentle, non-invasive, and continuously monitors for about 3 days.
  • Early detection could help doctors save transplanted tissue and improve recovery.
  • It's for people having 'free tissue transfer' surgery for head and neck cancer.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years or older, and planning to have free tissue transfer surgery for head and neck cancer. This means doctors are moving skin, muscle, or bone from one part of your body to your head or neck to repair an area after cancer removal. The doctors also need to be able to easily see the area where the new tissue is being placed.

There are certain reasons why you wouldn't be able to join. For example, if you have another very serious medical condition or illness, or if your cancer has spread to other parts of your body (doctors call this metastatic disease), you wouldn't be eligible. Also, if you are pregnant or breastfeeding, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Are you having 'free tissue transfer' surgery for head and neck cancer?
  3. Is the transplanted tissue going to be easily visible?
  4. Are you not pregnant or breastfeeding?
  5. Do you not have another serious medical condition or cancer that has spread?
Answer every question to see your result.

What does participation involve?

If you join this study, the main part of it involves using a new monitoring device. After your free tissue transfer surgery, this device will be placed on your transplanted tissue. It's designed to be gentle and will continuously check your blood flow for about three days (72 hours). This is a non-invasive device, meaning it won't break your skin. During this time, the medical team will also carry out their usual checks on your transplanted tissue. There are no extra medications involved due to this study, nor any extra hospital visits beyond your normal recovery. The device will be removed after 72 hours, and there's no long-term follow-up specifically for the study itself.

Potential risks and benefits

Taking part in this study may offer the benefit of potentially spotting any blood flow problems in your transplanted tissue earlier, which could improve the chances of a successful outcome from your surgery. However, studies like this also have some risks. While the device is designed to be gentle, there's always a small chance of skin irritation where it's placed. Also, the device is still being tested, so it might not work perfectly. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

  • Surrey Memorial Hospital
    Verified postcode
    Surrey, Canada
  • Vancouver General Hospital
    Verified postcode
    Vancouver, Canada

Common questions

What is 'free tissue transfer'?

It's a surgery where doctors move skin, muscle, or bone from one part of your body to another to repair a wound, often after cancer removal.

What does the new device do?

It's a gentle device that sits on your skin and uses light to continuously check the blood supply in your transplanted tissue for about three days after surgery.

Why is it important to check blood supply?

If the transplanted tissue doesn't get enough blood, it can be damaged. Early detection means doctors can try to fix it quickly, potentially saving the tissue.

Will this device hurt?

No, it's designed to be gentle and non-invasive, meaning it won't break your skin and should cause minimal discomfort.

How long will the device stay on?

It will continuously monitor your transplanted tissue for about 72 hours (three days) after your surgery.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Monitoring Free Tissue Transfer Hemodynamics Using NIRS…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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