NCT00830271已完成不适用
Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 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
研究组 & 干预措施
Vicryl plus/Monocryl plus
Experimental
Vicryl plus and Monocryl plus is the active comparator arm. These are the "active" sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery.
干预措施: Vicryl plus and Monocryl plus (Device)
vicryl/monocryl
Placebo Comparator
"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control.
干预措施: wound closure with Vicryl and Monocryl (Device)
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 (1)
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