CTRI/2017/01/007717已完成未知
A prospective, multi-center, randomized, controlled, single-blind, comparative study to evaluate safety and efficacy of MITSUâ?¢ Polyglactin 910 Suture with coated Vicrylâ?¢ Polyglactin 910 Suture in closure of surgical incision. - MITSUâ?¢ Polyglactin 910 Suture
Meril EndoSurgery Pvt Ltd0 个研究点目标入组 122 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 122
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
入选标准
- •1) Both male and female aged gteater than or equal to 18 years old.
- •2) Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
- •3) Subjects scheduled for closure of surgical incision where general soft tissue approximation and/or ligation is required
- •during elective surgery by using either MITSU Polyglactin 910 Suture of Meril Endo-Surgery Pvt. Ltd (study product) or Vicryl Polyglactin 910 Suture of Ethicon, Inc.(comparator) as per the discretion of principal investigator.
- •4) Subject agrees not to participate in any other investigational or invasive study for a period of 6 months.
- •5) Subject agrees to comply with all protocol requirements and protocol specific follow-up visits.
排除标准
- •1) Subject with history of HIV or any other systemic infections.
- •2) Subject in any case requiring other emergency operations (major surgical procedure).
- •3) Subject with on-going sepsis or septicaemia or on-going bacterial infections or on antibiotic treatment (other than prophylaxis antibiotics given prior to and post surgery).
- •4) Subject with history of prior surgery in recent past (within 1 month) with surgical site infection.
- •5) Patient with positive Urine pregnancy test (using urine pregnancy test kits) other than patient require the gynaecological surgical procedure.
研究者
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