RecruitingNAINTERVENTIONAL

Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

This study aims to find out if a special dressing, called Prevena (a type of negative pressure therapy), is better than standard dressings for helping wounds heal after surgery for Soft Tissue Sarcoma (STS). STS is a type of cancer that affects soft tissues like muscle or fat. Patients in this study have already had radiotherapy before their surgery. Researchers want to see if the special dressing can reduce problems with wound healing. This is important because radiotherapy before surgery can sometimes lead to more wound issues, even though it has other benefits. The study compares the two types of dressings to see which is more effective in preventing complications.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Leon Berard

Enrolment target

166

Start

03 Aug 2023

Estimated completion

01 Nov 2026

Soft Tissue Sarcoma

What is this study about?

This research study is designed to help us understand the best way to care for surgical wounds in people who have had a type of cancer called Soft Tissue Sarcoma (STS). STS affects soft parts of the body like muscles, fat, and blood vessels. The standard treatment often involves surgery to remove the cancer.

Sometimes, patients have radiotherapy (radiation treatment) before surgery. This can be very helpful for controlling the cancer locally, meaning it's less likely to come back in the same area. However, a potential downside of having radiotherapy before surgery is that it can sometimes make wound healing more difficult and increase the chance of problems after the operation.

This study is looking at two different types of dressings used after surgery: a standard dressing and a special dressing called Prevena. Prevena uses a gentle suction, known as negative pressure, to help wounds heal. The researchers want to see if using the Prevena dressing can reduce the number of wound complications, which would mean patients could get the benefits of pre-surgery radiotherapy without the higher risk of wound problems. They are comparing how well wounds heal with each type of dressing.

Key takeaways

The study compares a special dressing vs. a normal one for surgical wounds.
It's for people with Soft Tissue Sarcoma who've had radiotherapy before surgery.
The aim is to reduce wound problems after surgery.
Participation involves being assigned to one of two dressing groups.
Results could help improve wound care for future patients.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with a primary Soft Tissue Sarcoma (STS) in their arm, leg, or body. To be considered, you must have already had external radiotherapy treatment for your STS, and your surgery to remove the cancer should be planned within 3 to 8 weeks after your radiotherapy ends.

You also need to be planning to have the wound closed completely after surgery, sometimes with the help of skin or tissue from other parts of your body. You should be able to attend follow-up visits and understand the study information. You must also have medical insurance and give your informed consent to participate.

You cannot join the study if you have certain other types of cancer like Ewing's sarcoma or osteosarcoma (bone cancers), or if your cancer has come back. You also can't participate if you need certain types of drainage tubes or if your wound isn't planned to be closed right after surgery, or if you've already had a surgery that didn't remove all the cancer effectively.

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 18 years old or older?
Do you have Soft Tissue Sarcoma in your arm, leg, or body?
Have you already had radiotherapy for your cancer, with surgery planned for 3-8 weeks later?
Is your surgical wound planned to be closed completely?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive one of two types of wound dressings after your surgery for Soft Tissue Sarcoma: either a special 'negative pressure' dressing (Prevena) or a standard wound dressing. This is a bit like flipping a coin to decide which group you are in. You and your doctors will know which dressing you are using. The healthcare team will monitor your wound healing closely after your surgery to see how well it's progressing. You will have several follow-up visits with the medical team to check on your wound and overall recovery. The full duration of your participation, including all follow-up checks, will be explained during the consent process.

Potential risks and benefits

Participating in this study might offer a potential benefit if the special negative pressure dressing proves to be more effective at preventing wound complications after your surgery than standard care. By joining, you'll also be contributing to important medical research that could help future patients. As with any medical treatment or study, there are potential risks, though the doctors will explain these thoroughly. There's always a chance the dressing might not work as well for you, or you could experience discomfort or side effects. Always remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

CHU Nantes
Verified postcode
Nantes, France· Recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting
Institut de Cancérologie de l'Ouest - Pays de Loire
Verified postcode
Angers, France· Recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Recruiting
CHRU Tours Hôpital Trousseau
Verified postcode
Chambray-lès-Tours, France· Recruiting
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Georges François Leclerc
Verified postcode
Dijon, France· Recruiting
Centre Oscar Lambert
Verified postcode
Lille, France· Recruiting
CHU Limoges
Verified postcode
Limoges, France· Recruiting
Institut du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
APHP Hôpital Cochin
Verified postcode
Paris, France· Not yet recruiting

Common questions

What is Soft Tissue Sarcoma?

Soft Tissue Sarcoma is a type of cancer that can develop in the soft tissues of the body, such as muscles, fat, blood vessels, and nerves.

What is 'negative pressure therapy'?

Negative pressure therapy is a way of treating wounds using a special dressing that applies gentle suction. This helps to remove fluid, reduce swelling, and promote healing.

Why is radiotherapy given before surgery?

Radiotherapy before surgery can help shrink the tumour and make it easier for surgeons to remove all the cancer, potentially reducing the chance of it coming back in that area.

Will I know which dressing I'm getting?

Yes, this is an 'open-label' study, which means both you and your medical team will know whether you are receiving the special negative pressure dressing or the standard dressing.

What does 'resected STS' mean?

'Resected STS' means that the Soft Tissue Sarcoma has been surgically removed (resected) from the body.

How to find out more

François Gouin, MD, Chirurgien

francois.gouin@lyon.unicancer.fr 0469855311 Official trial record

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