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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Botulinum toxin injection
DrugIntervention 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Upper ArmExperimental treatment 1 intervention
Group B: Lower ArmExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Month 6Secondary outcomes
1
Measure of scar width in millimeters
Time frame
Month 3, month 6, month 12 and month 182
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).
Time frame
Month 3, month 6, month 12 and month 183
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).
Time frame
Month 3, Month 6, Month 12 and Month 184
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).
Time frame
Month 3, Month 12 and Month 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: