NCT00830271已完成不适用
Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- reduction of surgical site infection
研究概览
简要总结
This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery
排除标准
- •patients unable to give consent or comply with follow up
- •patients undergoing surgery for benign disease
- •patients with inflammatory cancers or skin ulceration
- •patients having neo-adjuvant chemotherapy or radiotherapy
- •patients with known allergy to triclosan antiseptic
- •patients with immune deficiency diseases
结局指标
主要结局
reduction of surgical site infection
时间窗: 6-7 months
次要结局
- estimation time in hospital and return to work numbers of haematomas and seromas(6-9 months)
研究者
研究点 (2)
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