Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact

NCT07013240 | Not Yet Recruiting Phase 3

• 1 other identifier: CHUBX 2024/31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sternotomy Closure,Open Heart Surgery

Keywords

scar; keloid; botulinum toxin; sternotomy

Outcome Measures

Primary Outcomes (1)

• 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).

  Month 6

Secondary Outcomes (6)

• Measure of scar width in millimeters

  Month 3, month 6, month 12 and month 18

• Evaluation of scar with POSAS : observer scale

  Month 3, month 6, month 12 and month 18

• Evaluation of scar with The Physician's Global Assesment (PGA)

  Month 3, Month 6, Month 12 and Month 18

• Evaluation of Stony Brooke Scar Scale score

  Month 3, Month 12 and Month 18

• Evaluation of scar with POSAS : Patient scale

  Month 3, Month 6, Month 12 and Month 18

Study Arms (2)

Upper Arm

EXPERIMENTAL

Intervention (botulinum toxin) in the upper half of the scar and placebo in the lower half

Drug: Botulinum toxin injection

Lower Arm

EXPERIMENTAL

Intervention (botulinum toxin) in the lower half of the scar, and placebo in the upper half.

Drug: Botulinum toxin injection

Interventions

Botulinum toxin injection DRUG

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.

Lower Arm; Upper Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 18090752 BACKGROUND

MeSH Terms

Conditions

Cicatrix; Keloid

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Robin ZAGALA, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin ZAGALA, MD

CONTACT

+335 56 79 56 79; robin.zagala@chu-bordeaux.fr

Claire BAZIN

CONTACT

+335 57 82 25 09; bazin.claire@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the Methodology Center and the Bordeaux University Hospital Pharmacy will have access to the correspondence list between the patient's number, the type of product and the area treated (lower or upper part of the scar). At no time during the study will investigators or patients have access to this list.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FR (1)