Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
Influence of the platysma suture on postoperative pain and wound healing.
详细描述
Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results.
Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary thyroid surgery
排除标准
- •previous neck surgery
- •application of wound drainages
- •preoperative diagnosed malignancy
- •surgical extension beyond thyroid resection (e.g. lymphadenectomy)
- •preexisting coagulopathy
- •preexisting chronic pain syndromes
- •preexisting dependency on pain reliefs
- •preexisting disorders in wound healing (e.g. diabetes mellitus)
- •intolerance to any study medication
结局指标
主要结局
Postoperative Pain
时间窗: Pain at morning of the first postoperative day
visual analogue pain scale (0-10)
次要结局
- wound infection(within 14 days postoperative)
- Cervical Seroma/Hematoma(14 days after surgery)
- Postoperative Pain(Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery)
- scar cosmesis(6 months after surgery)
- Disorders of the functional anatomy of the neck(At six months postoperative)