2025-521290-14-00招募中3 期
Immediate post-surgical Botulinum toxin injections to prevent dystrophic Scars after sternotomy : a placebo-controlled randomized clinical trial - BotuCiSter
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
The main objective was to evaluate the improvement of scar appearance by botulinum toxin injection in the immediate postoperative period after sternotomy, according to the Stony Brook Scar Evaluation Scale.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years old or over
- •Surgery with sternotomy
- •Covered by medical insurance
- •Patient able to attend follow-up visits
- •Patient able to sign informed consent
排除标准
- •Known allergy to botulinum toxin type A or to one of BOTOX®'s excipients (human albumin, sodium chloride)
- •Subclinical or clinical manifestations of abnormal neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)
- •Peripheral motor neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
- •Treatment with drugs that interfere directly or indirectly with neuromuscular transmission (aminoglycosides, curares, anticholinesterase agents, aminoquinoline, cyclosporine, etc.)
- •History of neuromuscular disorders
- •Injection site infection
- •Previous surgery with general anesthesia (curarization) in the month prior to inclusion
- •Pregnancy or breastfeeding
- •Persons under court protection, guardianship or conservatorship
结局指标
主要结局
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).
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).
次要结局
- 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
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (1)
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