Sternotomy Closure,Open Heart SurgeryPhase 3BotuCiSterNCT07013240
Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact
A Phase 3 study testing Botulinum toxin injection in people with Sternotomy Closure,Open Heart Surgery, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Sternotomy scars, which are localized in a high-tension area are often dystrophic, hypertrophic or keloidal, and can be difficult to accept to patients who already endured a heavy intervention with high psychologic impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy Closure,Open Heart Surgery
- What is being tested?
- Botulinum toxin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2025to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older
- Scheduled sternotomy at Bordeaux University Hospital within the next 4 months
- Person affiliated with or benefiting from a social security system
- Patient able to attend follow-up visits required by the study
- Free, informed, and written consent signed by the participant or an impartial witness (in case the participant is unable to write) and the investigator (no later than the day of inclusion)
Who cannot join
- Known allergy to botulinum toxin type A or any excipient in BOTOX® (human albumin, sodium chloride)
- Neuromuscular transmission disorder (myasthenia gravis or Lambert-Eaton syndrome)
- Motor peripheral neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
- Infection at the injection sites
- Pregnancy or breastfeeding
- Person under protection measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
Robin ZAGALA, MD, +335 56 79 56 79, robin.zagala@chu-bordeaux.fr
Claire BAZIN, +335 57 82 25 21, bazin.claire@chu-bordeaux.fr
About this study
Official title: Immediate Post-surgical Botulinum Toxin Injections to Prevent Dystrophic Scars After Sternotomy : a Placebo-controlled Randomized Clinical Trial
Sternotomy scars, which are localized in a high-tension area are often dystrophic, hypertrophic or keloidal, and can be difficult to accept to patients who already endured a heavy intervention with high psychologic impact. The investigators wish to evaluate immediate post-surgical injection of botulinum toxin to improve scar aspect and impact. A randomized, placebo-controlled, split-scar clinical trial will determine the improvement of scar aspects assessed by standardized scores (SBSES, POSAS), patient satisfaction and tolerance.
Read the detailed description
Adult wound healing does not restore the original skin architecture, and results in fibrotic scars. Specifically in high-tension areas and due to activation of fibrogenesis pathways, wound healing processes can lead to pathological scarring, hypertrophic scars, or keloids. The anterior thoracic region is one the body area suggested to the highest tensions, and sternotomies are performed perpendicularly to the lines of skin tension. Therefore, sternotomy scars are often dystrophic, inaesthetic and fibrous, or even hypertrophic. Depending on geographical distribution, sternotomy scars are found hypertrophic in 10 % to more than 50 % of cases. Aesthetic impact or related symptoms such as pruritus and pain impair psychological state and alter quality of life of these patients who endured a frequently difficult to handle surgical procedure.
Botulinum toxin type A is a neurotoxin derived from Clostridium botulinum culture. Through inhibition of pre-synaptic acetylcholine release, it induces local muscle paralysis that is reversible in a few months. Its interest is widely described in urology and neurology. Its dermatologic uses include the cosmetic purpose to reduce face wrinkles and the functional purpose to reduce hyperhidrosis. Its safety is well established. It has been proposed in the prevention and treatment of hypertrophic scars and keloids, and has been shown to reduce TGFß1, a main actor of fibrogenesis and pathological scarring. Through reduction of myofibroblastic differentiation, it downregulates mechanisms leading to dystrophic scars.
It was proposed in the improve scar aspect after surgical procedures, and early post-operative local injections showed efficacy in thyroidectomies, mammoplasties, or face surgeries to enhance scar aspect. Regarding sternotomy, a single study in China with a small sample (17 patients) studied post-operative injections (8 to 14 days after) of botulinum toxin. This split-scar study reported significant improvement of Vancouver Scar Scale, scar width and patient satisfaction in the treated site, at 6 months.
The authors aim to evaluate immediate post-operative botulinum toxin after sternotomies, to improve scar aspect through standardized scores (Stony Brook Scar Evaluation Scale, Patient and Observer Scar Assessment Scale) and impact through patient satisfaction at 6 and 18 months. The double-blind randomized placebo-controlled trial will be conducted in split-scar method, with administration for each patient of treatment (botulinum toxin) or placebo (saline) in the upper or lower part of scar, according to randomization.
Each patient will serve as its own control and will be evaluated for up to 18 months by a dermatological team, following standardized monitoring, including objective and subjective scores, as well as tolerance data.
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Being tested
- Botulinum toxin injection
- Keywords
- scar, keloid, botulinum toxin, sternotomy
- Medical subject headings
- Cicatrix, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDrug
Intervention will be made immediately after surgery, still under general anesthesia, by the cardiac surgeon, after suture.
Each patient will receive (either in the lower part or the upper part of the scar according to randomization) 50 international units (IU) of type A botulinum toxin (Botox®, Allergan aesthetics) diluted in 1 mL of saline to enable injection of 5 IU at each point, every centimeter, at 1 cm of each scar side.
An equivalent volume of saline will be injected under the same modalities in the other part of the scar.
| Study group | Role | What they receive |
|---|---|---|
| Upper Arm | Experimental | Intervention (botulinum toxin) in the upper half of the scar and placebo in the lower half Receives: Drug: Botulinum toxin injection |
| Lower Arm | Experimental | Intervention (botulinum toxin) in the lower half of the scar, and placebo in the upper half. Receives: Drug: Botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Stony Brooke Scar Scale score
The Stony Brook Scar Evaluation Scale (SBSES) was developed by Singer et al. in 2007. It is based on five scar indicators: width, elevation or depression, color, suture or staple marks, and overall appearance.Each indicator is assigned a score between 0 and 5 points. These scores are totaled to obtain the final score between 0 and 5 points. This score will be determined for each half of scar (superior part and inferior part).
Measured: Month 6
Secondary outcomes (6)
Measure of scar width in millimeters
Measured: Month 3, month 6, month 12 and month 18
Evaluation of scar with POSAS : observer scale
The observer's POSAS scale comprises six parameters (vascularity, pigmentation, thickness, relief, elasticity and surface).
Each parameter is rated on a scale from 1 ("normal skin") to 10 ("worst scar imaginable").
The sum of the six parameters constitutes the observer's total POSAS score scale .
In addition, a general opinion is scored from 1 to 10. All parameters should preferably be compared to normal skin on a comparable a comparable anatomical region.
This scale will be determined for each half of scar (superior part and inferior part).
Measured: Month 3, month 6, month 12 and month 18
Evaluation of scar with The Physician's Global Assesment (PGA)
The Physician's Global Assesment (PGA) evaluates the scar based on whether it is considered an Invisible scar ; a Scar as fine as a pencil line, of a color similar to the adjacent skin ; a Visible scar, little infiltrated or flat, discreetly colored ; a Widened and infiltrated scar, visible suture lines, of a color contrasting with the skin ; a Hypertrophic scar, raised, hypervascularized or very hyperpigmented ; a Keloid.
This evaluation will be determined for each half of scar (superior part and inferior part).
Measured: Month 3, Month 6, Month 12 and Month 18
Evaluation of Stony Brooke Scar Scale score
The Stony Brook Scar Evaluation Scale (SBSES) was developed by Singer et al. in 2007. It is based on five scar indicators: width, elevation or depression, color, suture or staple marks, and overall appearance. Each indicator is assigned a score between 0 and 1 point. These scores are totaled to obtain the final score between 0 and 5 points.
This scale will be determined for each half of scar (superior part and inferior part).
Measured: Month 3, Month 12 and Month 18
Evaluation of scar with POSAS : Patient scale
The patient's POSAS scale comprises six parameters (pain, itching, color, stiffness, thickness and irregularity).
Each parameter is rated on a scale from 1 ("normal skin") to 10 ("worst scar imaginable").
In addition, a general opinion is scored from 1 to 10. The sum of all these parameters constitutes the patient's total POSAS score scale.
All parameters should preferably be compared to normal skin on a comparable a comparable anatomical region.
This evaluation will be determined for each half of scar (superior part and inferior part).
Measured: Month 3, Month 6, Month 12 and Month 18
Satisfaction numerical scale
Scar satisfaction is rated on a scale from 0 ("not at all satisfied") to 10 ("extremely satisfied").
This scale will be determined for each half of scar (superior part and inferior part).
Measured: Month 3, Month 6, Month 12 and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start5 Jul 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sternotomy Closure,Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin ZAGALA, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013240
- Sponsor's protocol ID
- CHUBX 2024/31
- Acronym
- BotuCiSter
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is available from Dr ZAGALA. An email can be sent to her so that she can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.
Publications
Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
PubMed 18090752
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post-surgical Botulinum Toxin Injections to Prevent Dystrophic Scars After Sternotomy : a Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07013240
- Acronym / sponsor ID
- BotuCiSter / CHUBX 2024/31
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Keywords
- scar, keloid, botulinum toxin, sternotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jul 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sternotomy scars, which are localized in a high-tension area are often dystrophic, hypertrophic or keloidal, and can be difficult to accept to patients who already endured a heavy intervention with high psychologic impact. The investigators wish to evaluate immediate post-surgical injection of botulinum toxin to improve scar aspect and impact. A randomized, placebo-controlled, split-scar clinical trial will determine the improvement of scar aspects assessed by standardized scores (SBSES, POSAS), patient satisfaction and tolerance.
Detailed description
Adult wound healing does not restore the original skin architecture, and results in fibrotic scars. Specifically in high-tension areas and due to activation of fibrogenesis pathways, wound healing processes can lead to pathological scarring, hypertrophic scars, or keloids. The anterior thoracic region is one the body area suggested to the highest tensions, and sternotomies are performed perpendicularly to the lines of skin tension. Therefore, sternotomy scars are often dystrophic, inaesthetic and fibrous, or even hypertrophic. Depending on geographical distribution, sternotomy scars are found hypertrophic in 10 % to more than 50 % of cases. Aesthetic impact or related symptoms such as pruritus and pain impair psychological state and alter quality of life of these patients who endured a frequently difficult to handle surgical procedure.
Botulinum toxin type A is a neurotoxin derived from Clostridium botulinum culture. Through inhibition of pre-synaptic acetylcholine release, it induces local muscle paralysis that is reversible in a few months. Its interest is widely described in urology and neurology. Its dermatologic uses include the cosmetic purpose to reduce face wrinkles and the functional purpose to reduce hyperhidrosis. Its safety is well established. It has been proposed in the prevention and treatment of hypertrophic scars and keloids, and has been shown to reduce TGFß1, a main actor of fibrogenesis and pathological scarring. Through reduction of myofibroblastic differentiation, it downregulates mechanisms leading to dystrophic scars.
It was proposed in the improve scar aspect after surgical procedures, and early post-operative local injections showed efficacy in thyroidectomies, mammoplasties, or face surgeries to enhance scar aspect. Regarding sternotomy, a single study in China with a small sample (17 patients) studied post-operative injections (8 to 14 days after) of botulinum toxin. This split-scar study reported significant improvement of Vancouver Scar Scale, scar width and patient satisfaction in the treated site, at 6 months.
The authors aim to evaluate immediate post-operative botulinum toxin after sternotomies, to improve scar aspect through standardized scores (Stony Brook Scar Evaluation Scale, Patient and Observer Scar Assessment Scale) and impact through patient satisfaction at 6 and 18 months. The double-blind randomized placebo-controlled trial will be conducted in split-scar method, with administration for each patient of treatment (botulinum toxin) or placebo (saline) in the upper or lower part of scar, according to randomization.
Each patient will serve as its own control and will be evaluated for up to 18 months by a dermatological team, following standardized monitoring, including objective and subjective scores, as well as tolerance data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Arm | Experimental | Drug: Botulinum toxin injectionIntervention (botulinum toxin) in the upper half of the scar and placebo in the lower half |
| Lower Arm | Experimental | Drug: Botulinum toxin injectionIntervention (botulinum toxin) in the lower half of the scar, and placebo in the upper half. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 years or older
- Scheduled sternotomy at Bordeaux University Hospital within the next 4 months
- Person affiliated with or benefiting from a social security system
- Patient able to attend follow-up visits required by the study
- Free, informed, and written consent signed by the participant or an impartial witness (in case the participant is unable to write) and the investigator (no later than the day of inclusion)
Key exclusion criteria (6 listed)
- Known allergy to botulinum toxin type A or any excipient in BOTOX® (human albumin, sodium chloride)
- Neuromuscular transmission disorder (myasthenia gravis or Lambert-Eaton syndrome)
- Motor peripheral neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
- Infection at the injection sites
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injectionIntervention will be made immediately after surgery, still under general anesthesia, by the cardiac surgeon, after suture. Each patient will receive (either in the lower part or the upper part of the scar according to randomization) 50 international units (IU) of type A botulinum toxin (Botox®, Allergan aesthetics) diluted in 1 mL of saline to enable injection of 5 IU at each point, every centimeter, at 1 cm of each scar side. An equivalent volume of saline will be injected under the same modalities in the other part of the scar. | Drug | Lower Arm, Upper Arm |
Primary outcome
Evaluation of Stony Brooke Scar Scale score
Time frame: Month 6
The Stony Brook Scar Evaluation Scale (SBSES) was developed by Singer et al. in 2007. It is based on five scar indicators: width, elevation or depression, color, suture or staple marks, and overall appearance.Each indicator is assigned a score between 0 and 5 points. These scores are totaled to obtain the final score between 0 and 5 points. This score will be determined for each half of scar (superior part and inferior part).
6 secondary outcomes
Measure of scar width in millimeters
Time frame: Month 3, month 6, month 12 and month 18
Evaluation of scar with POSAS : observer scale
Time frame: Month 3, month 6, month 12 and month 18
Evaluation of scar with The Physician's Global Assesment (PGA)
Time frame: Month 3, Month 6, Month 12 and Month 18
Evaluation of Stony Brooke Scar Scale score
Time frame: Month 3, Month 12 and Month 18
Evaluation of scar with POSAS : Patient scale
Time frame: Month 3, Month 6, Month 12 and Month 18
Satisfaction numerical scale
Time frame: Month 3, Month 6, Month 12 and Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 18090752Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
- Individual participant dataSharing planned: Yes. The data is available from Dr ZAGALA. An email can be sent to her so that she can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin ZAGALA, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin injection in people with Sternotomy Closure,Open Heart Surgery, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin ZAGALA, MD (+335 56 79 56 79, robin.zagala@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Stony Brooke Scar Scale score (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.