CTRI/2020/12/029737已完成4 期
Single blind randomized study comparing clinical equivalence of polyglycolic acid suture (Truglyde�®) and polyglactin-910 suture (Vicryl�®) for subcutaneous tissue closure after cesarean delivery
Healthium Medtech Pvt Ltd0 个研究点目标入组 116 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
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. Primiparous or multiparous women aged 18-40 years with a singleton pregnancy
- •2. Women undergoing cesarean section by Pfannenstiel incision
- •3. Women with good systemic/ mental health as per opinion of investigator
- •4. Women with CDC surgical wound classification class I
- •5. Women who have given written informed consent
排除标准
- •1. Women with haemoglobin levels <7g/dL
- •2. Women who donââ?¬•t require subcutaneous suturing
- •3. Women with a history of similar surgical procedure (suprapubic transverse scar, pfannensteil incision, laparoscopic procedure)
- •4. Women having urogenital tract infection or chorioamnionitis within 2 weeks before cesarean delivery
- •5. Women who will have a stillbirth
- •6. Women in whom surgical plan is for a vertical skin incision
- •7. Women with history of allergy to the suture materials
- •8. Women with history of bleeding disorders
- •9. Women already participating in another trial
- •10. Women who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant
- •11. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •12. Other indication-based exclusion, in opinion of investigator
研究者
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