NCT03108742已完成不适用
Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Modified Stony Brook Scar Evaluation Scale (SBES)
研究概览
简要总结
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who will have thyroid surgery
排除标准
- •done thyroid surgery before
- •done any radiotherapy on neck
- •who needs neck dissection
- •laparoscopic ot robotic surgery
- •under 18 years old or over 70 years old
- •bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
- •who used immunosuppressive drugs in 6 months
- •breast feeder or pregnancy
- •who disagrees to do this trial
研究组 & 干预措施
classic intradermal suture
Active Comparator
干预措施: classic intradermal suture (Procedure)
dermal stapler
Experimental
干预措施: INSORB (Device)
结局指标
主要结局
Modified Stony Brook Scar Evaluation Scale (SBES)
时间窗: Change from Baseline scar at 6 months
Evaluate scar
Manchester Scar Scale (MSS)
时间窗: Change from Baseline scar at 6 months
Evaluate scar
Visual Analogue Scale (VAS)
时间窗: Change from Baseline pain at 6 months
Evaluate pain
次要结局
未报告次要终点
研究者
研究点 (1)
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