AuthorisedTherapeutic confirmatory (Phase III)Interventional

Immediate post-surgical Botulinum toxin injections to prevent dystrophic Scars after sternotomy : a placebo-controlled randomized clinical trial - BotuCiSter

This research study, called BotuCiSter, is investigating whether a medicine called Botulinum toxin (Botox) can help make scars less noticeable after a type of heart surgery called a sternotomy. When you have a sternotomy, a cut is made down the middle of your chest. The study compares giving a Botox injection to one side of the fresh scar and a dummy injection (placebo) of salt water to the other side. Doctors want to see if the Botox side looks better after 6 months, using special scoring systems. This is a Phase III study, meaning it's a larger trial to confirm if the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Enrolment target

Start

06 Aug 2025

Surgery with sternotomy

What is this study about?

When you have open-heart surgery, doctors need to make a cut down the centre of your chest, which is called a sternotomy. This leaves you with a scar. Scientists are always looking for ways to help these scars heal better and look less noticeable. This study is testing if a medicine called Botulinum toxin, more commonly known as Botox, can help with this.

After your sternotomy surgery, if you choose to take part in this study, the fresh scar will be divided in half down its length. One half will receive a very small injection of Botox, and the other half will receive an injection of a salt water solution, which is known as a placebo. The salt water acts as a dummy treatment, so doctors can accurately compare the effects of Botox against no active treatment. Neither you nor the doctors assessing your scar will know which side received Botox and which received the placebo – this is called 'blinding'.

The main goal is to see if the side treated with Botox looks significantly better than the side treated with the placebo when assessed by a dermatologist after 6 months. They will use a special scale to score the appearance of the scar. They will also check the scars at different times over 18 months, looking at things like scar width and how both you and doctors feel about the scar's appearance. The aim is to find effective ways to improve scar healing after significant surgeries like sternotomy.

Key takeaways

This study tests if Botox helps sternotomy scars look better.
Half of your fresh scar gets Botox, the other half gets a dummy treatment (placebo).
Scar appearance is checked with special scores over 18 months.
This is a Phase III trial, aimed at confirming treatment effectiveness.
Participation means contributing to research that could help future patients.

Who may be eligible?

This study is designed for adults aged 18 and over who are having heart surgery that requires a sternotomy (a cut down the middle of the chest). Both men and women are welcome to take part.

To be considered for the study, you must be well enough to have the surgery and agree to follow all the study procedures. The research team will carefully check your medical history to make sure that taking part in the study is safe and appropriate for you.

If you are interested in joining, the study doctors will go through a detailed checklist with you to make sure you meet all the requirements.

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?
Are you having heart surgery that involves a sternotomy?
Are you able to attend follow-up appointments for 18 months?
Do you understand that you might receive either Botox or a non-active solution in your scar?
Are you generally healthy enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive injections into your new sternotomy scar shortly after your surgery. One half of your scar will be injected with Botox, and the other half with a salt water solution (placebo). You won't know which side gets which. After this, you will have follow-up visits where a dermatology team will examine your scar and take measurements. These visits will happen at 3 months, 6 months, 12 months, and 18 months after your surgery. They will use special scales to rate your scar's appearance, width, and how you feel about it. The total duration of your participation, including all follow-up, will be 18 months.

Potential risks and benefits

Potential benefits of taking part could include the chance to improve the appearance of your sternotomy scar. You would also be contributing to medical knowledge that might help future patients. As with any medical procedure, there are potential risks, such as bruising, swelling, or infection at the injection site. Botox itself has rare side effects, which the study team will discuss in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
France

Common questions

What is a sternotomy?

A sternotomy is a surgical cut made down the middle of your chest, usually during open-heart surgery, to allow doctors to access your heart.

What is Botox, and why might it help a scar?

Botox (Botulinum toxin) is a medicine known for relaxing muscles. Researchers think that by relaxing the skin around a new scar, it might reduce tension and help the scar heal more smoothly.

Will I feel pain from the injections?

The injections are given shortly after surgery, when the area may still be numb from anaesthesia. Any discomfort would be minimal, and discussed with you by the medical team.

What does 'placebo' mean?

A placebo is a 'dummy' injection, in this case, a simple salt water solution that has no active medicine. It helps researchers compare the real effect of the Botox.

How long will I be involved in the study?

You'll be involved for about 18 months in total, including follow-up visits to check on your scar's healing.