CTRI/2012/12/003170Other4 期
A Prospective Phase IV, cross over, single centre, investigator blinded study to evaluate the efficacy of Contractubex® Gel in the reduction and prevention of post surgery hypertrophic scar and keloid in subjects having undergone surgery by Sternotomy - NI
MS Clinical Research Pvt Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Males and females with recent (within 20 days) cardiac surgery.
- •Age: 18 years or older
- •The subject willing and able to complete the entire course of the trial and comply with the trial instructions
- •Written informed consent
排除标准
- •Any other planned topical treatment in the scar area
- •Any surgical wound discharge like purulent and serous at the time of initiation of therapy.
- •Tumorigenic changes in the area to treat, independent of tumor dignity
- •Any severe or uncontrolled systemic disease (e.g. pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection
- •Known allergy or sensitivity to the trial medication or its components.
- •Non compliant subjects
- •Psychiatric problems which, in the investigatorâ??s opinion, are severe enough to interfere with the trial results
- •Participation in another clinical trial within 30 days prior to screening
研究者
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