Immediate post-surgical Botulinum toxin injections to prevent dystrophic Scars after sternotomy : a placebo-controlled randomized clinical trial - BotuCiSter

Conditions

Surgery with sternotomy

Brief summary

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).

Detailed description

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), 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, 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., 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

Related papers

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Interventions

DRUGSODIUM CHLORIDE SOLUTION 0.9%

DRUGBOTOX 50 UNITÉS ALLERGAN

DRUGpoudre pour solution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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), 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, 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., 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	—

Measure

Time frame

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), 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, 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., 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

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Countries

France

Outcome results

None listed