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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

13 criteria

  • 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)
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Investigated drugs

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.

What is already known about the treatment

Botulinum toxin - A purified neurotoxin administered through local injections that temporarily blocks nerve signals to muscles, reducing tension and movement in the targeted area. This medication is widely recognized in medical literature and approved for both therapeutic and cosmetic uses, including scar prevention and management after surgical procedures. In post-sternotomy applications, it works by paralyzing the surrounding muscles, thus reducing mechanical forces on the healing wound and potentially improving scar appearance. The substance belongs to the neurotoxin class of medications and functions by blocking the release of acetylcholine at nerve endings, which prevents muscle contractions in the treated area.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521290-14-00Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

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