NCT05149118已完成4 期
Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up
研究概览
简要总结
The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital
排除标准
- •age younger than 20 years or older than 60 years
- •history of keloid development
- •requirement for modified radical neck dissection
- •previous neck surgery
- •current pregnancy or breast feeding
- •allergy to PDRN
- •taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants
- •uncontrolled medical diseases
结局指标
主要结局
modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up
时间窗: at 3 months
modified Vancouver Scar Scale (0 normal skin\~15 worst)
次要结局
- Subjective symptoms at the 3-month follow-up(at 3 months)
- Erythema and pigmentation at the 3-month follow-up(at 3 months)
- Scar Height (mm) at the 3-month follow-up(at 3 months)
研究者
Jung-Won Shin
Associate Professor
Seoul National University Bundang Hospital
研究点 (2)
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