Single-blind, randomized study comparing clinical equivalence of MonoglydeÃ?Â® and MonocrylÃ?Â®, absorbable poliglecaprone 25 sutures, for subcuticular skin closure at cesarean delivery

Healthium Medtech Pvt Ltd0 个研究点目标入组 132 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Primiparous or multiparous women aged 18-40 years, with a singleton pregnancy
•2. Women with good systemic/ mental health as per opinion of investigator
•3. Women with CDC surgical wound classification class I
•4. Women who have given written informed consent

•1. Women with BMI >27 Kg/m2
•2. Women with hemoglobin levels <7g/dL
•3. Women with a history of similar surgical procedure (suprapubic transverse scar, pfannensteil incision, laparoscopic procedure)
•4. Women having urogenital tract infection within 2 weeks before cesarean delivery
•5. Women in whom surgical plan is for a vertical skin incision
•6. Women with history of allergy to the suture materials
•7. Women with history of bleeding disorders
•8. Women already participating in another trial
•9. Women who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant
•10. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
•11. Other indication-based exclusion, in opinion of investigator

发起方

Healthium Medtech Pvt Ltd