RecruitingNAINTERVENTIONAL

Laser Speckle Imaging During Breast Reconstruction

Every year, thousands of women in the UK have breast reconstruction after cancer. Unfortunately, many experience healing problems because of poor blood flow to the reconstructed breast. This study is testing a new, non-touch camera that shows blood flow during surgery, which surgeons can't usually see. Early results suggest this camera can spot areas with good or bad blood flow, which helps predict healing. The researchers believe this device could help surgeons choose healthier tissue, leading to fewer healing issues. This current study will involve 60 women having breast reconstruction. Half will have surgery with the camera, and half without. The goal is to see if a much larger trial to properly test the camera is possible and acceptable, and how much information can be collected over six months.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrolment target

Start

25 Apr 2024

Estimated completion

01 May 2025

Breast Cancer

What is this study about?

Many women choose to have breast reconstruction after breast cancer surgery, which can really help them feel better about themselves. However, a significant number of these women, perhaps 3 or 4 out of every 10, face difficulties with healing after their operation. These problems can be quite upsetting and often mean more medical care or even further surgeries are needed. These healing issues are often linked to poor blood flow to the skin and deeper tissues that are used to rebuild the breast.

Researchers have developed a clever new device that uses a special camera to look at blood flow in the skin. The best part is, it doesn't even touch the skin and shows clear, continuous pictures of how well blood is flowing – a level of detail surgeons can’t normally see during an operation. They've already used this camera during breast reconstruction surgeries and found it accurately showed where blood flow was poor, leading to healing problems, and where it was good, resulting in fewer difficulties after surgery. These problems ranged from minor things like slower healing to major issues like losing the newly reconstructed breast.

The people running this study believe this camera could really help surgeons pick the healthiest skin and tissues during breast reconstruction. This could potentially help more women heal smoothly without problems. However, before they can run a large study to prove this, they need to check if such a trial is practical and acceptable to patients, the surgical team, and other hospital staff. This small study will involve 60 women having breast surgery. They will be split into two groups: 30 women will have their surgery as usual, and 30 will have the blood flow camera used during their operation. All participants will be followed up for six months to see how they heal and track any problems. The findings from this initial study will be used to plan a much bigger trial to properly test if the blood flow camera truly improves patient recovery and is good value for money for the NHS.

Key takeaways

A new camera is being tested during breast reconstruction surgery.
The camera shows blood flow in the skin without touching it.
Poor blood flow can cause healing problems after breast reconstruction.
This study aims to help plan a larger trial to improve patient healing.
60 women will take part, with half having the camera used during surgery and half not.

Who may be eligible?

This study is looking for women aged 18 or over who are having breast reconstruction surgery. You must be able and willing to understand what the study involves and give your agreement to take part.

The breast reconstruction you are having needs to be a specific type called 'autologous free flap surgery'. This kind of surgery uses your own body tissue to rebuild the breast. It can be done either straight after your breast cancer removal (a mastectomy) or at a later date.

Unfortunately, if you are unable to give written permission to join the study, you won't be able to take part.

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.

Are you a woman aged 18 or older?
Are you having breast reconstruction using your own body tissue (autologous free flap surgery)?
Are you having this surgery either right after your mastectomy or at a later date?
Are you able to understand the study and agree to take part in writing?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be one of 60 women in this study. You will be randomly placed into one of two groups. One group will have their breast reconstruction surgery as planned, without the new blood flow camera being used. The other group will have the new blood flow camera used during their surgery. The camera takes pictures of your skin's blood flow but does not touch you.

After your surgery, the research team will keep track of your healing and any problems you might experience while you are in the hospital. They will also continue to check in with you for six months following your operation to record any issues. This will help them understand how well you are recovering and how much information they can collect during this period.

Potential risks and benefits

This study aims to discover if a new imaging device can help surgeons improve outcomes for women having breast reconstruction. While there's no direct benefit to you from being in this specific study (as it's mainly about planning a larger trial), you would be helping researchers gather important information that could lead to better healing for future patients. For those having the imaging, the device does not touch you and there are no known direct risks associated with simply taking pictures of blood flow. As with all medical research, you are free to withdraw from the study at any time without explaining why, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Devon University Healthcare NHS Foundation Trust
Verified postcode
Exeter, United Kingdom· Recruiting

Common questions

What is breast reconstruction surgery?

It's an operation to rebuild the shape of your breast, often after it's been removed due to cancer. This study focuses on a type using your own body tissue.

What is 'poor blood flow' and why is it a problem?

Poor blood flow means not enough blood is reaching a part of your body. In reconstruction, it can stop the new tissue from healing properly, leading to problems.

What is the new 'Laser Speckle Imaging' device?

It's a special camera that takes pictures of the blood flowing in your skin during surgery. It doesn't touch you and helps surgeons see things they can't normally see.

Will this device change my surgery?

No, if you are in the group where the device is used, it will only take pictures during your surgery. It will not change how the surgery is performed.

How long will I be involved in the study?

You will be followed up while you are in hospital and then for six months after your surgery to see how you are healing.

How to find out more

Lucy Gates, PhD

lucy.gates1@nhs.net 01392 408181 Official trial record

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