RecruitingNAINTERVENTIONAL

BREAST ADM Trial for Alloplastic Breast Reconstruction

This research study is looking at different types of special 'mesh' materials used during breast reconstruction. When you have a mastectomy, these meshes help to support a new breast created with an implant. There are a few different types of these materials available, and doctors aren't sure which one is the best clinically. This study will compare four of these materials (AlloDerm, AlloMax, DermACELL, and Flex HD) to see which leads to fewer complications and better recovery for patients over two years. By understanding this, doctors can make more informed choices for patients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

328

Start

25 Nov 2020

Estimated completion

31 Dec 2025

Breast Reconstruction

What is this study about?

When a woman has a mastectomy (surgery to remove a breast, often due to cancer), she might choose to have breast reconstruction to rebuild the shape of her breast. One common way to do this is a two-stage process. First, a tissue expander is put in, which is like a temporary balloon that slowly stretches the skin to make room for a permanent implant. During this first surgery, doctors often use a special 'mesh' material to help support the tissue expander and create a good pocket for the future breast implant.

There are several different types of these 'mesh' materials available, such as AlloDerm, AlloMax, DermACELL, and Flex HD. While they all aim to do the same job – provide support and help the reconstruction heal – doctors don't yet know if one works significantly better than the others in terms of preventing problems or ensuring a smoother recovery. This study wants to find out which of these four common mesh materials is the most effective.

The main goal is to compare how often problems occur after surgery with each type of mesh, particularly an issue called seroma (a build-up of fluid that sometimes needs treatment). By carefully watching patients for two years after their surgery, the researchers hope to understand which material leads to the best results for women having this type of breast reconstruction. This information will help doctors make better decisions about which mesh to use for their patients in the future, aiming for the safest and most successful outcomes.

Key takeaways

Compares four types of support 'mesh' used in breast reconstruction.
Aims to find out which 'mesh' has the fewest complications.
Participation involves random assignment to one of the four types of 'mesh'.
Patients will be followed for two years after surgery.
Helps improve future treatment choices for breast reconstruction.

Who may be eligible?

This study is looking for women aged between 21 and 65 years old who are having breast reconstruction after a mastectomy. You would be eligible if your reconstruction involves a two-stage process, meaning you'll first have a tissue expander and then later have it swapped for a permanent breast implant, and if special 'mesh' material is going to be used as part of this process.

However, some things would mean you couldn't take part. For example, if you're having a different type of reconstruction (where your own body tissue is used, not an implant), or if you've had breast reconstruction before. You also couldn't join if you've had radiation treatment to your breast area in the past, or if your doctor believes breast reconstruction isn't safe for you.

Other reasons for not being able to join include having a specific type of armpit surgery (axillary node dissection with clearance), an allergy to certain medications like Polysporin, or an allergy to components found in one of the specific mesh materials (like Gentamicin or Vancomycin for DermACELL). Also, if during your mastectomy surgery, the surgeon sees that the skin is not healthy enough, they might decide it's not safe for you 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 between 21 and 65 years old?
Are you having a mastectomy with breast reconstruction?
Will your reconstruction use a tissue expander followed by an implant, with 'mesh' material?
Have you NOT had breast reconstruction before?
Have you NOT had radiation treatment to your breast area?
Are you NOT allergic to Polysporin or certain antibiotics like Gentamicin/Vancomycin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the type of special 'mesh' material used in your breast reconstruction surgery will be chosen randomly, like flipping a coin, from one of the four types being studied. You and your care team won't know which type you're getting until after the surgery, but the research team will keep track.

After your surgery, the study team will closely monitor your recovery and any complications you might experience, especially looking for fluid build-up (seroma) that needs treatment. This monitoring will continue for two years after your initial surgery. You will have regular check-ups with your surgeon, and your progress will be recorded during these appointments. There are no additional medications to take as part of this study, beyond your usual post-operative care.

Potential risks and benefits

Taking part in this study may not directly benefit you, as the type of 'mesh' material you receive will be chosen at random. However, the information gathered from this study will help future patients by improving doctors' understanding of which materials work best. As with any surgery, there are risks involved in breast reconstruction, and these are not changed by being in the study. Potential risks of using these mesh materials can include infection, fluid collection, or issues with healing, which are the same as if you were not in the study. You will receive standard care regardless of whether you participate. You are free to withdraw from the study at any time without affecting your medical care.

Locations (4)

Mount Saint Joseph's Hospital
Verified postcode
Vancouver, Canada· Recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
UBC Hospital
Verified postcode
Vancouver, Canada· Recruiting
Saint Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'mesh' in breast reconstruction?

It's a special material used during breast reconstruction surgery to help support the tissue expander and hold it in place, shaping the new breast area.

Will I know which mesh I receive?

No, the specific type of mesh you receive will be chosen at random by the study, and you won't know which one it is during your treatment to keep the results fair.

How long will I be followed in this study?

The study will actively monitor your recovery and progress for two years after your breast reconstruction surgery.

Can I still get breast reconstruction if I don't join the study?

Yes, joining this study is completely your choice and will not affect your ability to have breast reconstruction as planned.

What is a 'seroma'?

A seroma is a build-up of fluid under the skin after surgery. In this study, they're looking at how often seromas happen and if they need draining or other treatment.

How to find out more

Dr. Nancy Van Laeken

nancy@vanlaeken.com 604-669-1633 Official trial record

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