Single blind randomized comparative study comparing clinical equivalence of two polyglactin 910 suture brands, TrusynthÃ?Â® and VicrylÃ?Â®, 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: 2022年10月17日

试验速览

暂无简介。

•1. Primiparous or multiparous women aged 18-40 years with a singleton pregnancy
•2. Women undergoing caesarean 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

•1. Women with hemoglobin levels <7g/dL
•2. Women who donÃ¢â?¬•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

发起方

Healthium Medtech Pvt Ltd