CTRI/2020/06/025935
Completed
Phase 4
Single-blind, randomized study comparing clinical equivalence of Monoglyde�® and Monocryl�®, absorbable poliglecaprone 25 sutures, for subcuticular skin closure at cesarean delivery
Healthium Medtech Pvt Ltd0 sites132 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Healthium Medtech Pvt Ltd
- Enrollment
- 132
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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