Botulinum toxin injection after sternotomies to improve scar aspect and impact

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Hospital of Bordeaux

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The main objective was to evaluate the improvement of scar appearance by botulinum toxin injection in the immediate postoperative period after sternotomy, according to the Stony Brook Scar Evaluation Scale.

Secondary objectives 4

1. Compare the two scar halves (immediate post-operative injection of botulinum toxin or placebo) with respect to scar appearance at 3, 6, 12 and 18 months in adults undergoing sternotomy surgery.
2. Compare the two scar halves (immediate post-operative injection of botulinum toxin or placebo) with respect to scarring experience in adults undergoing sternotomy surgery.
3. Compare the two scar halves (immediate post-operative injection of botulinum toxin or placebo) with respect to local tolerance.
4. Compare the two scar halves (immediate post-operative injection of botulinum toxin or placebo) in subgroups defined by dystrophic scar risk factors, vis-à-vis SBSES) at 6 months, SBSES at 18 months and satisfaction scale at 18 months.

Conditions and MedDRA coding

Surgery with sternotomy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient aged 18 years old or over
2. Surgery with sternotomy
3. Covered by medical insurance
4. Patient able to attend follow-up visits
5. Patient able to sign informed consent

Exclusion criteria 9

1. Known allergy to botulinum toxin type A or to one of BOTOX®'s excipients (human albumin, sodium chloride)
2. Subclinical or clinical manifestations of abnormal neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)
3. Peripheral motor neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
4. Treatment with drugs that interfere directly or indirectly with neuromuscular transmission (aminoglycosides, curares, anticholinesterase agents, aminoquinoline, cyclosporine, etc.)
5. History of neuromuscular disorders
6. Injection site infection
7. Previous surgery with general anesthesia (curarization) in the month prior to inclusion
8. Pregnancy or breastfeeding
9. Persons under court protection, guardianship or conservatorship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparison of means of the Stony Brook Scar Evaluation Scale (SBSES) at 6 months (M6) (collected by a dermatology team assessor, blinded to randomization) for each scar half (treated with botulinum toxin injection or placebo).

Secondary endpoints 4

1. Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for scar width (mm)
2. Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for the Patient and Observer Scar Assessment Scale (POSAS): observer scale
3. Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for the Physician's Global Assesment.
4. Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M12 and M18 for Stony Brook Scar Evaluation Scale

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Bordeaux

Sponsor organisation

Centre Hospitalier Universitaire De Bordeaux

Address

12 Rue Dubernat

City

Talence

Postcode

33400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Coordinating investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Coordinating investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications