RecruitingNAINTERVENTIONAL

Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery

This research is investigating a special dressing called negative pressure therapy (NPT) for women undergoing complex breast cancer surgery. After such surgery, complications like infections or problems with healing can sometimes occur, ranging from 2% for simpler surgeries to over 20% for more complex ones like reconstruction. These problems can delay other important treatments, affect how the breast looks, and generally impact a woman's well-being. Previous small studies have hinted that NPT might help reduce these complications, but more thorough research is needed. This new study aims to see if using this special dressing can significantly reduce healing problems after complex breast cancer surgery, ultimately improving recovery and quality of life for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

254

Start

15 Apr 2025

Estimated completion

01 Jul 2027

Breast Cancer

What is this study about?

When someone has breast cancer, surgery is often a very important part of the treatment. Sometimes, after this surgery, especially if it's a more complicated type like having the breast rebuilt (reconstruction) at the same time, healing can be a challenge. We know that problems with wound healing, such as infections or issues with the scar, can happen in a significant number of cases. These problems can be distressing for patients and can even delay other vital treatments, like chemotherapy or radiotherapy, which are crucial for fighting the cancer.

Because of these potential issues, doctors are always looking for better ways to help wounds heal properly. One idea is using something called negative pressure therapy (NPT). This involves a special dressing that creates a gentle suction over the wound. Some earlier, smaller studies have suggested that NPT might help reduce complications like infections and aid in better wound healing after breast cancer surgery. However, these past studies weren't always very strong or large enough to give clear answers. They had some limitations, like comparing different groups of people who weren't quite alike.

This new study aims to get much clearer answers. It will carefully examine whether applying negative pressure therapy after complex breast cancer surgery can truly lower the risk of healing problems. By finding out if this special dressing works well, doctors hope to improve recovery for women, help them restart other treatments sooner, and ultimately, make the healing process smoother and more comfortable after such an important surgery.

Key takeaways

This study investigates a special dressing (NPT) for complex breast cancer surgery.
The goal is to reduce wound healing problems like infections and poor scarring.
Previous small studies suggest NPT might help, but more robust research is needed.
Participation involves either the NPT dressing or a standard dressing.
Improving healing can potentially lead to better recovery and fewer delays in other treatments.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with breast cancer. You might be eligible if your doctor has planned for you to have a complex breast surgery, such as a mastectomy (removal of the breast) with immediate reconstruction (building a new breast at the same time) or a special type of breast reshaping surgery called oncoplasty.

You also need to have at least one of certain risk factors that might make wound healing more difficult. These include being overweight (BMI of 30 or more) or having large breasts (cup size E or bigger), currently smoking or having quit less than a month ago, having diabetes, having had radiation therapy to the breast before, or taking long-term steroid medication. You must also be able to understand and sign a consent form, and be prepared to attend all planned appointments.

You would not be able to join if you are pregnant or breastfeeding, legally unable to make your own decisions, already taking part in another study focused on wound healing, or need surgery on your other breast at the same time.

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?
Do you have breast cancer, and is your doctor planning complex breast surgery (e.g., mastectomy with immediate reconstruction or oncoplasty)?
Do you have risk factors like obesity, smoking, diabetes, or previous breast radiotherapy?
Are you able to attend all study appointments and sign a consent form?
Are you NOT pregnant or breastfeeding, and NOT currently in another wound healing study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference will be the type of dressing used on your surgical wound. Some participants will receive the special negative pressure therapy dressing, and others will have a standard dressing. The doctors and nurses monitoring you will not know which type of dressing you received to keep the study fair. You will have regular check-ups to monitor your healing and overall health, similar to what you would normally have after breast surgery. The total duration of your participation in the study, including follow-up appointments, will be explained fully by the study team.

Potential risks and benefits

Taking part in this study may offer the potential benefit of improved wound healing and fewer complications if the negative pressure therapy proves effective. However, there's also a chance you might receive the standard dressing, and the new therapy might not work better than usual care. As with any medical study, there's always a small risk of unforeseen side effects from the experimental treatment or the need for extra appointments. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Centre Georges-François Leclerc
Verified postcode
Dijon, France· Not yet recruiting
Centre Hospitalier de Nîmes
Verified postcode
Nîmes, France· Recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Not yet recruiting
Centre Hospitalier de Montpellier
Verified postcode
Montpellier, France· Recruiting
Institut régional du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
Institut de Cancérologie de l'Ouest
Verified postcode
Angers, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Not yet recruiting

Common questions

What is negative pressure therapy (NPT)?

NPT is a special type of dressing that uses gentle suction over your wound to help it heal better and reduce fluid build-up.

Will I know if I'm getting the special dressing?

No, to keep the study fair, neither you nor your doctors will know which type of dressing you're receiving (the special NPT or a standard one).

What kind of breast surgery is this for?

This study is for women having complex breast cancer surgery, such as removal of the breast with immediate reconstruction, or a special breast reshaping surgery.

Why is it important to prevent wound healing problems?

Preventing problems helps you recover better, can avoid delays in other cancer treatments, and can improve how your breast looks and feels after surgery.

What are the common risks that this study focuses on?

The study is looking at risks like infections, problems with the scar, and issues where skin tissue might not heal properly after surgery.

How to find out more

Mathias NERON, MD

mathias.neron@icm.unicancer.fr 467614813 Official trial record

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