NCT01496404已完成不适用
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Versus Scalpel for Surgical Skin Incisions
St. Paul's Hospital, Canada2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Scar Cosmesis
研究概览
简要总结
The aim of this research project is to compare electrocautery to scalpel for laparotomy skin incisions, with the following objectives:
- To investigate whether electrocautery produces a cosmetically inferior surgical scar.
- To compare the rates of wound infection with each technique.
- To determine if electrocautery results in less postoperative pain. Our null hypothesis is that electrocautery is equivalent to scalpel for creating skin incisions; with respect to wound cosmesis, wound infection rate, and post-operative pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 19 years old
- •bowel resection surgery
- •incision is 3cm or larger
排除标准
- •Diagnosed with a connective tissue disease (e.g. Systemic lupus, scleroderma, polymyositis, dermatomyositis, Marfan syndrome, Ehler's Danlos, etc.)
- •The site of planned surgery has a previous surgical scar.
结局指标
主要结局
Scar Cosmesis
时间窗: 6 months
At 6 months post-operative, patients' scars will be evaluated by two independent trained blinded observers who will use the Patient Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale (VSS) to evaluate the cosmesis of the surgical scar. Patients, who are blinded to the type of incision they have received, will also subjectively assign a score to their scar using the POSAS.
次要结局
- Wound Infection Rate(within 6 months post-operatively)
- Post-operative wound pain(within 5 days post-operatively)
研究者
Dr. Carl J Brown
Head, Division of General Surgery, Providence Health Care
St. Paul's Hospital, Canada
研究点 (2)
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