Undermining During Cutaneous Wound 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
研究概览
简要总结
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
详细描述
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining 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 with diameter > 3 cm
- •Wounds unable to be fully closed without undermining
研究组 & 干预措施
Wound Closure without Undermining
One side of the wound will remain un-undermined.
干预措施: Wound Closure without Undermining (Procedure)
Wound Closure with Undermining
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
干预措施: Wound Closure with Undermining (Procedure)
Wound Closure with Undermining
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
干预措施: Wound Closure without Undermining (Procedure)
Wound Closure without Undermining
One side of the wound will remain un-undermined.
干预措施: Wound Closure with Undermining (Procedure)
结局指标
主要结局
Assessment of Scar on the Patient and Observer Scar Assessment Scale
时间窗: 3 months
After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
次要结局
- Assessment of Complications(3 months)
- Measurement of Scar Width(3 months)