Study of botulinum toxin type A injections to prevent scarring in patients after heart surgery with sternotomy

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What is this study about?

This clinical trial studies the effects of botulinum toxin injections in preventing abnormal scarring after sternotomy surgery (an operation where the breastbone is cut to access the heart). The study compares Botox injections to sodium chloride solution (placebo) when administered immediately after surgery. The purpose is to evaluate whether botulinum toxin can improve the appearance of surgical scars.

During the study, patients who undergo sternotomy will receive injections along their surgical wound. One half of the surgical scar will be treated with Botox, while the other half will receive placebo. Both substances will be administered through intradermal injection (injection into the skin). The treatment involves a single injection session performed shortly after the surgery.

The appearance of the surgical scar will be evaluated over time by skin specialists who will not know which part of the scar received which treatment. These evaluations will continue for up to 18 months after surgery to determine if there are differences between the Botox-treated and placebo-treated areas of the scar. The study will assess various aspects of scar healing, including the scar’s width and overall appearance.

1 Initial treatment after surgery

After your sternotomy (chest surgery), you will receive two types of injections along your surgical scar:

One half of the scar will receive botulinum toxin injections

The other half will receive sodium chloride solution (0.9%) injections

Both substances will be administered through intradermal injection (into the skin)

2 3-month follow-up visit

A dermatology specialist will examine your scar

The specialist will measure the scar width

Your scar will be evaluated using specific assessment scales

The evaluation will be performed on both halves of the scar

3 6-month follow-up visit

A dermatology specialist will perform a detailed scar evaluation

The specialist will measure the scar width

Your scar will be assessed using the Stony Brook Scar Evaluation Scale

Additional assessment scales will be used to evaluate the scar appearance

4 12-month follow-up visit

A dermatology specialist will conduct another scar examination

The specialist will measure the scar width

Your scar will be evaluated using multiple assessment scales

Both halves of the scar will be compared

5 18-month follow-up visit

Final scar examination by a dermatology specialist

Final scar width measurement

Final evaluation using assessment scales

Completion of the study participation

Who Can Join the Study?

  • Must be 18 years of age or older
  • Must have undergone or be scheduled for sternotomy (a surgical procedure where the breastbone is cut open to access the heart)
  • Must have valid medical insurance coverage
  • Must be able to attend all follow-up appointments as scheduled by the research team
  • Must be able to understand and sign the informed consent form (a document that explains the study details and patient rights)
  • Can be either male or female
  • Must not be part of any vulnerable population groups (such as prisoners or mentally impaired individuals)

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous chest surgery involving sternotomy (surgical cutting of the breastbone)
  • Known allergy or sensitivity to botulinum toxin
  • Pregnancy or breastfeeding
  • Current infection at the surgical site
  • History of abnormal scarring (keloids – raised, thick scars)
  • Use of medications that can interact with botulinum toxin
  • Neuromuscular disorders that could be affected by botulinum toxin
  • Inability to follow post-operative care instructions
  • Current participation in other clinical trials
  • Uncontrolled medical conditions that could affect wound healing
  • History of bleeding disorders
  • Immunocompromised conditions (weakened immune system)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
05.05.2025

Trial locations

Botulinum toxin is a medication that helps reduce muscle tension and movement in specific areas. When injected into the skin and muscles around a surgical incision immediately after heart surgery (sternotomy), it may help prevent the formation of raised, thick scars. The medication works by temporarily relaxing the muscles around the surgical site, which may reduce tension on the healing wound and potentially lead to better scar formation.

Post-sternotomy Scarring – A condition that develops after cardiac or thoracic surgery involving sternotomy, where the breastbone is cut vertically to access the heart or chest cavity. The healing process results in scar tissue formation along the incision line. The scar typically appears as a vertical line down the center of the chest and can vary in width and appearance. During the initial healing phase, the scar may appear red and raised, gradually changing color and texture over time. The scarring process involves the formation of new collagen fibers and can continue for several months after surgery.

Trial ID:
2025-521290-14-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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