Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
研究概览
简要总结
The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elliptical surgical wound that needs to be closed with a layered closure
- •Wound 3 cm in length or longer
排除标准
- •Incarceration
- •Active pregnancy
- •Less than 18 years of age
- •Unable to give informed consent
- •Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
- •Wound closure projected to be less than 3 cm in length
- •Skin less than 3 mm in thickness (dermis and epidermis combined)
结局指标
主要结局
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
时间窗: 3 months
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows: a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Scar width
时间窗: 3 months
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
次要结局
- Height of scar immediately following wound closure(5 minutes)