ISRCTN57443262已完成未知
A randomised, controlled, patient and assessor blind pilot study of a collagen implant (GentaFleece™) for the prevention of sternal wound infection in cardiac surgery
Plymouth Hospitals NHS Trust (UK)0 个研究点目标入组 200 人开始时间: 2011年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or older, either sex
- •2. Undergoing cardiac surgery through the sternum (sternotomy)
- •3. Provided informed consent to participate
排除标准
- •1. Patients admitted for emergency surgery
- •2. Pregnant or lactating females
- •3. Patients with a known hypersensitivity to collagen and/or gentamicin and other aminoglycoside antibiotics
- •4. Patients with a history of autoimmune diseases in which gentamicin is contraindicated (e.g., Parkinson's disease or myasthenia gravis)
- •5. Serum creatinine more than 200 µmol/l within 2 weeks pre-operatively
- •6. Chronic renal failure on dialysis
- •7. Participating in another clinical research study
研究者
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