Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
研究概览
简要总结
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.
详细描述
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.
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
- None
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
- •Able to give informed consent themselves
- •Patient scheduled for cutaneous surgical procedure with predicted linear closure
- •Willing to return for follow up visits
排除标准
- •Mentally handicapped
- •Incarceration
- •Pregnant Women
- •Wounds with predicted closure length less than 3 cm
- •Wounds unable to be fully closed via primary closure
研究组 & 干预措施
Dermal Suturing Only Wound Closure
The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
干预措施: Layered Cutaneous Wound Closure (Procedure)
Dermal Suturing Only Wound Closure
The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
干预措施: Dermal Suturing Only Wound Closure (Procedure)
Layered Cutaneous Wound Closure
The side assigned to layered closure is closed with 5-0 fast acting gut.
干预措施: Dermal Suturing Only Wound Closure (Procedure)
Layered Cutaneous Wound Closure
The side assigned to layered closure is closed with 5-0 fast acting gut.
干预措施: Layered Cutaneous Wound Closure (Procedure)
结局指标
主要结局
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
时间窗: 12 months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
时间窗: 3 months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
次要结局
- Measurement of Scar Width(3 months and 12 months)
- Assessment of Complications(3 months and 12 months)