A trial looking at using a sheet of tissue to improve breast reconstruction surgery (POBRAD)

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

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at using a sheet of tissue to help improve the outcome of surgery to make a new breast shape (breast reconstruction) after having a breast removed (mastectomy). This trial is for women who are having breast reconstruction using an implant.

If you have surgery to remove a breast affected by cancer (mastectomy), you can have a new breast shape formed by the surgeon. This is called breast reconstruction. You can have this at the same time as your mastectomy (immediate reconstruction). We already know that immediate reconstruction can give good cosmetic results. But doctors are always trying to improve results.

The researchers think a sheet of tissue called acellular dermal matrice (ADM) may help. The ADM is a sheet of skin tissue taken from a pig or calf specially treated to remove all living cells so that your body will not react to it as something from outside your body. This means it will not cause an immune response Open a glossary item . Surgeons put the ADM under the skin to provide extra cover and support for the implant.

The aim of this trial is to find out if using the ADM can improve the outcome of immediate breast reconstruction surgery with an implant.

Who can enter

You may be able to enter this trial if you are attending Guy’s and St Thomas’ Hospital and you are

Having surgery to remove your whole breast
Having an immediate breast reconstruction using an implant (Please note if you are having breast reconstruction using an implant and body tissue you cannot take part)

Trial design

This phase 2 trial will recruit 40 women. If the results are promising the researchers will do a phase 3 trial with a larger number of women.

You have your breast reconstruction surgery as usual. In addition to putting your implant in the surgeon will put a sheet of tissue (ADM) under your skin.

The researchers will ask you to fill in a questionnaire 1 month and 18 months after surgery. They will also ask your permission to take a photograph of your breast before and after surgery.