NCT03843866Unknown不适用
The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.
St. James's Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cosmesis
研究概览
简要总结
Cosmesis postoperatively is an important consideration for both patients and surgeons and consequently surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds.
Therefore the investigators are using two different close techniques for laparoscopic wounds. These are; 1. sutures with steri-strips and 2. adhesive bond.
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
- Single (Outcomes Assessor)
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
- •Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.
排除标准
- •Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.
研究组 & 干预措施
Suture & steri-strips
Active Comparator
干预措施: 4-0 Monocryl (Other)
Adhesive Glue
Active Comparator
干预措施: Adhesive Glue (Other)
结局指标
主要结局
Cosmesis
时间窗: 6 months
Cosmetic outcome being graded by patient and clinician via questionnaire. Observer scar assessment form (1-10) 1 = worst result possible, 10 being the best result possible.
次要结局
- Surgical site infection (SSI).(6 months)
研究者
Noel Edward Donlon
General Surgery Specialist Registrar
St. James's Hospital, Ireland
研究点 (1)
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