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Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact
Sponsor: University Hospital, Bordeaux
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.
Official title: Immediate Post-surgical Botulinum Toxin Injections to Prevent Dystrophic Scars After Sternotomy : a Placebo-controlled Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-07-05
Completion Date
2027-02-28
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
Botulinum toxin injection
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.
Locations (1)
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France