NCT05149118已完成4 期
Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 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
研究组 & 干预措施
PDRN injected group
Experimental
The participants in treatment group had received two consecutive injections of PDRN one day and two days after the surgery. A total 1mL of PDRN was injected along the suture line at distance of 1cm in each session.
干预措施: Polydeoxyribonucleotide (PDRN) (Procedure)
Control group
No Intervention
The participants in control group were left untreated.
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 (1)
Loading locations...
相似试验
已完成
4 期
Polydeoxyribonucleotide (PDRN) for Cuff RegenerationRotator Cuff TearNCT03916198Chuncheon Sacred Heart Hospital79
已完成
4 期
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic UlcersDiabetic UlcerFoot Ulcer UnhealedNCT00638872University of Messina215
招募中
不适用
The effect of polydeoxyribonucleotide for wound healing and scar prevention after thyroidectomyDiseases of the skin and subcutaneous tissueKCT0004251Seoul National University Bundang Hospital44
撤回
不适用
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the HipChondral LesionsFemoroacetabular ImpingementNCT02183896University of Colorado, Denver
Unknown
不适用
The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical WoundsWound Infection and Wound HealingNCT02869204Jens Rikardt Andersen40