Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Botulinum toxin injection
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov