CompletedInterventional

Comparison of outcomes on breast reconstruction using two tissue spreading techniques during mastectomy procedure

When having a mastectomy with immediate breast reconstruction, keeping the skin healthy is vital. Surgeons need to lift skin out of the way to see clearly during the operation. They usually do this with metal tools called retractors, but these tools can pinch tissue and lower blood flow. Some surgeons prefer to use their fingers instead. This study, based in Cambridge, compares both methods in women having both breasts removed and rebuilt at the same time. During the operation, the surgeon uses metal tools on one breast and their fingers on the other. A special glowing dye is injected into a vein to measure blood flow in both sides. Taking part involves filling in quality-of-life forms before and after surgery, and rating your pain levels over the first six weeks. The aim is to make breast surgery safer for future patients.

At a glance

Status

Completed

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

06 Mar 2024

Estimated completion

17 Dec 2025

Breast surgery

What is this study about?

When women have a mastectomy (breast removal surgery) with immediate reconstruction, surgeons carefully save the skin over the breast to cover the new implant or tissue. For the new breast to heal well, this skin must keep a healthy blood supply. If the blood supply is damaged during the operation, it can cause problems such as poor healing, infections, or even the loss of the reconstruction.

To see what they are doing during surgery, doctors have to lift and hold back the skin and tissue. They usually use metal instruments called retractors. While these tools give a clear view, pulling on the tissue can sometimes bruise delicate blood vessels. Some surgeons use their fingers to hold the tissue instead, which may be gentler and protect blood flow. At the moment, doctors do not know for sure which method is better.

This trial compares the two methods directly. In each patient having both breasts removed, the surgeon will use metal tools on one breast and fingers on the other. During the operation, an anaesthetist will inject a small amount of a safe medical dye called indocyanine green (ICG) into your bloodstream. A special camera tracks this dye to show exactly how much blood is reaching the skin on each side.

By comparing both methods in the same person, researchers hope to see which technique gives the best blood flow. The results could help surgeons across the NHS choose the safest, gentlest way to perform breast reconstructions in the future.

Key takeaways

The trial compares using metal tools versus fingers to gently lift tissue during a double mastectomy.
The goal is to find out which method keeps blood flow to the skin healthier.
Open to women aged 18+ having both breasts removed and rebuilt at the same time.
A special camera and glowing dye will measure skin blood flow during the operation.
Follow-up involves pain checks and questionnaires over four to six weeks of routine recovery.

Who may be eligible?

This study is open to women aged 18 and over who are scheduled to have both breasts removed (a bilateral mastectomy) and reconstructed at the same time. This may be because of breast cancer in both breasts, or as a preventative measure to reduce breast cancer risk due to family history or genes.

To take part, you must be having the same type of reconstruction on both sides. You also need to have healthy liver and kidney function, which is checked with routine blood tests before surgery.

You cannot join this study if you have breast cancer that has spread into the skin, or if you have had radiotherapy or major surgery on one breast in the past. It is also not suitable for people with an overactive thyroid or known allergies to iodine or medical dyes.

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.

I am a woman aged 18 or over.
I am scheduled to have both breasts removed (double mastectomy) and rebuilt in the same operation.
I am having the same type of reconstruction on both breasts.
I do not have an allergy to iodine or medical dyes.
I do not have an overactive thyroid condition.
I have not had radiotherapy on either breast in the past.

Answer every question to see your result.

What does participation involve?

If you agree to take part, you will first fill out a short questionnaire about your breast health and well-being at a normal clinic visit before your operation.

On the day of your surgery, everything proceeds under general anaesthetic as planned, but the surgeon will use metal retractors on one breast and their fingers on the other. Your anaesthetist will inject a small amount of harmless glowing dye (ICG) into your drip at three points during the operation so a camera can measure blood flow in your skin.

After surgery, nursing staff will check your pain scores at 18 hours. You will then have your usual follow-up checks at 1 week, 2 weeks, and between 4 to 6 weeks. At your 4 to 6-week visit, you will answer one final questionnaire about your recovery. In total, your participation lasts about six weeks after your surgery.

Potential risks and benefits

Taking part will not give you any direct personal benefit, as both surgical techniques are already safe, standard ways of doing this operation. However, your involvement will help doctors improve surgical techniques for women having breast reconstructions in the future. The risks of taking part are very similar to routine surgery. The main extra risk is a possible allergic reaction to the glowing dye, although this is uncommon. Joining the study is completely voluntary, and you can withdraw at any time without affecting your normal NHS care.

Locations (1)

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

Addenbrookes Hospital
City only
Cambridge, England

Common questions

Will taking part make my operation take longer?

Injecting the dye and taking pictures takes only a few minutes, so it will not noticeably change the length of your operation or your time under anaesthetic.

Will my two breasts look or heal differently?

Both techniques are standard surgical methods already used in hospitals. The goal is to see which gives better blood flow, but both are designed to help your skin heal normally.

Is the glowing dye safe?

Yes. Indocyanine green (ICG) is widely used in hospital tests and clears out of your body naturally through your liver. Allergic reactions can happen, but they are rare.

Do I have to travel for extra hospital appointments?

No. All checks and questionnaires take place during your regular hospital visits before and after your planned operation.

Can I leave the study if I change my mind?

Yes, you are free to stop taking part at any time. You do not need to give a reason, and your medical team will continue to give you the best possible care.

How to find out more

Alexandra Azevedo

alex.azevedo@nhs.net +44 1223 348 454 Official trial record

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